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BACKGROUND AND OBJECTIVES: In this secondary analysis of a pilot clinical trial with individuals with alcohol and nicotine use disorders, we investigate the relationship between serum concentrations of oxytocin, ß-endorphin, melatonin, α-melanocyte-stimulating hormone, substance P, and orexin, with objective biomarkers (salivary cotinine and serum γ-glutamyl transferase [GGT]) as well as with self-reported smoking and alcohol drinking. METHODS: Biomarkers for a total of N = 19 participants were analyzed using multiplexed, competitive format immune-assay (peptides) and enzyme competitive immunoassay (saliva). A regression analysis using Pearson's correlation coefficient was utilized to determine correlations. We controlled for multiple comparisons, checked for collinearities, and ran two-sided statistical tests. RESULTS: We found significant positive correlations for cotinine and oxytocin (P = .002), ß-endorphin (P = .008), and orexin (P < .001), but not for either GGT or self-reported smoking or alcohol drinking. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: These preliminary results suggest a relationship between cotinine and oxytocin, ß-endorphin, and orexin, which opens up new potential hypotheses on the potential role of these endocrine pathways in tobacco smokers. (Am J Addict 2021;30:88-91).

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AIMS: The goal of this study was to evaluate the efficacy of topiramate up to 200 mg/day and of aripiprazole up to 15 mg/day, alone and combined, in reducing alcohol-related outcomes in a human laboratory study. METHOD: This was a 5 week, between-subject, double-blind, placebo-controlled human laboratory study with topiramate [0 mg/day (placebo), 100 mg/day, 200 mg/day] and aripiprazole [0 mg/day (placebo), 7.5 mg/day, 15 mg/day] in 90 non-treatment seeking, heavy drinking, alcohol-dependent individuals. Main outcomes were the efficacy of 200 mg/day topiramate and 15 mg/day aripiprazole, alone and combined, in reducing drinks consumed during an alcohol self-administration procedure (human laboratory phase) and while receiving the study medications prior to the laboratory session (naturalistic drinking phase). Other outcomes in the laboratory phase included alcohol craving, and alcohol biphasic effects. RESULTS: In the human laboratory phase, topiramate 200 mg/day reduced alcohol craving [**P < 0.01] and amplified alcohol-induced stimulation [*P < 0.05], but did not reduce the number of drinks consumed. Topiramate 200 mg/day was also effective in reducing drinking days [*P < 0.05], and alcohol craving [*P < 0.05], in the naturalistic drinking phase. No significant findings were found for aripiprazole for any of the outcomes analyzed. CONCLUSION: Participants receiving 200 mg/day topiramate reported reduced alcohol drinking and craving, and increased alcohol-related stimulation. These findings provide further support for the role of topiramate as a pharmacological treatment for AUD. CLINICALTRIAL.GOV IDENTIFIER: NCT00884884. SHORT SUMMARY: This study tested topiramate and aripiprazole alone and in combination. The results replicate past findings and suggest that topiramate may be an effective treatment for alcohol use disorder. The present results suggest that the combination of topiramate and aripiprazole do not warrant further evaluation.

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BACKGROUND: Preclinical and clinical research suggest that the α1 receptor antagonist prazosin reduces alcohol consumption. Furthermore, clinical studies indicate a role for prazosin in treating Post-Traumatic Stress Disorder (PTSD) symptoms and a recent trial suggested that pre-treatment blood pressure (BP) predicts therapeutic response for prazosin in PTSD patients. Whether pre-treatment BP may predict response to α1 blockers in alcohol-dependent (AD) patients is unknown. We previously reported a randomized controlled trial (RCT) where doxazosin, an α1 receptor antagonist with a more favorable pharmacokinetic profile than prazosin, reduced drinks per week (DPW) and heavy drinking days (HDD) in AD patients with a high family history density of alcoholism. In this study, we tested pre-treatment BP as another potentially valuable clinical moderator of doxazosin's response on alcohol consumption. METHODS: This was a double-blind placebo-controlled RCT testing doxazosin up to 16mg/day in AD treatment-seeking patients (N=41). The hypothesized moderator effect of baseline standing systolic and diastolic BP on DPW and HDD was tested. RESULTS: With pre-treatment standing diastolic BP as a moderator, there were significant BP x medication interactions for both DPW [**p=0.009, d=0.80] and HDD [*p=0.018, d=1.11]. Post-hoc analyses indicated significant doxazosin effects in patients with higher standing BP in reducing both DPW and HDD. CONCLUSION: These findings suggest that higher standing diastolic BP at baseline (pre-treatment) may represent a predictor of doxazosin's response on alcohol consumption in AD patients. These results further elucidate the possible efficacy and mechanisms of action of α1 receptor antagonism in AD individuals.

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BACKGROUND: The Important People and Activities (IPA) instrument assesses network characteristics and social support for drinking and abstinence. The IPA has garnered widespread use in the alcohol treatment field. We modified the IPA to assess HIV status, drug of choice, and IV drug use among social network members. Further, we queried frequency of unprotected sex, between the participant and network members. AIM: Since this measure was modified, and the test-retest reliability of the IPA has only rarely been examined, we conducted a small substudy (n=26) to examine 1-week test-retest reliability of this measure. METHODS: Participants were individuals in a day treatment program with an SUD and/or AUD diagnosis. RESULTS: Drug of choice for the participants represented roughly equal thirds of heroin, cocaine, and alcohol. The sample was 62% female and 39% Latino/a. At pretest 198 persons were named on the MIPA (M=7.6 network members per subject). It was determined that 152 of the people were overlapping between the test and retest. CONCLUSIONS: Percent agreement, ICCs, and kappas for the items ranged from acceptable to excellent across the two time periods. Classification of network members as positive, negative, or neutral influences on sobriety also demonstrated good to excellent kappas.

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BACKGROUND: Increasing evidence supports a role for appetite-regulating pathways like ghrelin, insulin, and leptin in alcoholism. We previously reported that intravenous (i.v.) exogenous ghrelin increases alcohol craving. We also reported i.v. ghrelin reduces endogenous serum leptin, whose levels, in turn, negatively correlated with alcohol craving. Exogenous ghrelin administration decreases insulin secretion both in vitro and in vivo experiments. This study tested the hypothesis that i.v. ghrelin may also decrease endogenous serum insulin levels in alcoholic individuals. Additionally, we explored possible correlations between serum insulin and alcohol craving, since a correlation between insulin and alcohol craving was previously reported. METHODS: This was a double-blind, placebo-controlled human laboratory study ( n =43). Non-treatment-seeking, alcohol-dependent, heavy drinkers were randomized to receive i.v. ghrelin or placebo, followed by an alcohol cue-reactivity procedure. RESULTS: There was a main effect for i.v. ghrelin, compared to placebo in reducing serum insulin ( P <.05). There was also a time effect ( P <.001) but not ghrelin x time interaction ( P >.05). We did not find a correlation between the reduction of serum insulin and alcohol craving ( P >.05). The change in serum insulin was consistent with a parallel reduction in serum connective-peptide in the ghrelin group compared with placebo, although this difference did not reach statistical significance ( P =.076). No similar effects were found for other glucose-regulating hormones analyzed i.e. glucagon, glucagon-like peptide-1, and gastric inhibitory peptide ( P s>.05). CONCLUSIONS: These findings indicate i.v. ghrelin administration has an effect on reducing serum insulin in alcohol-dependent individuals; however, the reduction of insulin did not correlate with changes in alcohol cue-elicited craving. We speculate that, unlike for leptin, the interactions between ghrelin and insulin relationship are limited at the peripheral level. However, mechanistic studies are needed to investigate this hypothesis.

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Evidence suggests that the norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been studied for AD. A double-blind placebo-controlled randomized clinical trial was conducted in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16 mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were the primary outcomes. Family history density of alcoholism (FHDA), severity of AD and gender were a priori moderators. Forty-one AD individuals were randomized, 30 (doxazosin = 15) completed the treatment phase and 28 (doxazosin = 14) also completed the follow-up. There were no significant differences between groups on DPW and HDD per week. With FHDA as a moderator, there were significant FHDA × medication interactions for both DPW (pcorrected = 0.001, d = 1.18) and HDD (pcorrected = 0.00009, d = 1.30). Post hoc analyses revealed that doxazosin significantly reduced alcohol drinking in AD patients with high FHDA and by contrast increased drinking in those with low FHDA. Doxazosin may be effective selectively in AD patients with high FHDA. This study provides preliminary evidence for personalized medicine using α1 -blockade to treat AD. However, confirmatory studies are required.

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RATIONALE: There is presently no approved single treatment for dual alcohol and nicotine dependencies. OBJECTIVE: This pilot study investigated baclofen effects in alcoholic smokers. METHODS: This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. RESULTS: Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. CONCLUSIONS: This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.

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The purpose of this exploratory study was to examine the interaction of 5-HTTLPR and DRD4 exon III polymorphisms with gender in non-treatment seeking alcohol-dependent (AD) individuals while alternately taking ondansetron and sertraline. Evidence suggests that alcohol dependence may be influenced by a genetic interaction that may be gender-specific with temporal changes making pharmacological treatment with serotonergic drugs complex. The main trial was a within-subject double-blind placebo-controlled human laboratory study with 77 non-treatment-seeking AD individuals randomized (55 completed, 49 complete data) to receive 200 mg/day of sertraline or 0.5 mg/day of ondansetron for 3 weeks followed by an alcohol self-administration experiment (ASAE), then placebo for 3 weeks followed by a second ASAE, then receive the alternate drug, in a counterbalanced order, for 3 weeks followed by a third ASAE. Results for men were not significant. Women with the LL 5-HTTLPR genotype receiving ondansetron and SS/SL 5-HTTLPR genotype receiving sertraline (matched), drank significantly fewer drinks per drinking day (DDD) during the 7 days prior to the first and third ASAEs than women receiving the mismatched medication (i.e., sertraline to LL and ondansetron to SS/SL). In a 3-way interaction, 5-HTTLPR alleles by DRD4 alleles by medications, women with the LL genotype who received ondansetron and had DRD4≥7 exon III repeats drank significantly fewer DDD as did SS/SL women who received sertraline but conversely had DRD4<7 repeats in the 7-day period leading up to the first and third ASAEs. Consistent with these data was a significant reduction of milliliters consumed ad libitum during these same ASAEs. These exploratory findings add possible support to gender and genetic differences among AD individuals in response to serotonergic pharmacotherapies. Future trials should be powerful enough to take into account that endophenotypes and a targeting of serotonergic interactions may be essential to successfully treat alcohol dependence.

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BACKGROUND: There is a need to identify novel pharmacologic targets to treat alcoholism. Animal and human studies suggest a role for ghrelin in the neurobiology of alcohol dependence and craving. Here, we were the first to test the hypothesis that intravenous administration of exogenous ghrelin acutely increases alcohol craving. METHODS: This was a double-blind, placebo-controlled human laboratory proof-of-concept study. Nontreatment-seeking, alcohol-dependent, heavy-drinking individuals were randomized to receive intravenous ghrelin 1 mcg/kg, 3 mcg/kg or 0 mcg/kg (placebo), followed by a cue-reactivity procedure, during which participants were exposed to neutral (juice) and alcohol cues. The primary outcome variable was the increase in alcohol craving (also called urge) for alcohol, assessed by the Alcohol Visual Analogue Scale. RESULTS: Out of 103 screenings, 45 individuals received the study drug. Repeated measures of analysis of covariance revealed a group effect across ghrelin doses in increasing alcohol craving (p < .05). A dose-specific examination revealed a significant effect of ghrelin 3 mcg/kg versus placebo in increasing alcohol craving (p < .05) with a large effect size (d = .94). By contrast, no significant ghrelin effect was found in increasing either urge to drink juice or food craving (p = ns). No significant differences in side effects were found (p = ns). CONCLUSIONS: Intravenous administration of exogenous ghrelin increased alcohol craving in alcohol-dependent heavy-drinking individuals. Although the small sample requires confirmatory studies, these findings provide preliminary evidence that ghrelin may play a role in the neurobiology of alcohol craving, thus demonstrating a novel pharmacologic target for treatment.

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BACKGROUND: One hypothesis suggests that the differential response to ondansetron- and serotonin-specific re-uptake inhibitors (SSRIs) may be due to a functional polymorphism of the 5'-HTTLPR promoter region in SLC6A4, the gene that codes for the serotonin transporter (5-HTT). The LL 5'-HTTLPR genotype is postulated to be specifically sensitive to the effects of ondansetron with SS/SL 5'-HTTLPR genotypes sensitive to SSRIs. This study tests this hypothesis by matching nontreatment-seeking alcohol-dependent (AD) individuals with LL genotype to ondansetron and SS/SL genotypes to the SSRI sertraline, and mismatching them assessing naturalistic and bar-laboratory alcohol drinking. METHODS: Seventy-seven AD individuals were randomized to 1 of 2 counterbalanced arms to receive sertraline 200 mg/d or ondansetron 0.5 mg/d for 3 weeks followed by an alcohol self-administration experiment (ASAE) and then received placebo for 3 weeks followed by a second ASAE. Individuals then received the alternate drug for 3 weeks followed by a third ASAE. Drinks per drinking day (DDD with drinks in standard drinking units) for 7 days prior to each ASAE and milliliters consumed during each ASAE were the primary outcomes. RESULTS: Fifty-five participants completed the study. The genotype × order interaction was significant, F(1, 47) = 8.42, p = 0.006, for DDD. Three analyses of covariance were conducted for DDD during the week before each ASAE. Ondansetron compared to sertraline resulted in a significant reduction in DDD during the week before the first, F(1, 47) = 7.64, p = 0.008, but not the third ASAE. There was no difference in milliliters consumed during each ASAE. CONCLUSIONS: This study modestly supports the hypothesis that ondansetron may reduce DDD in AD individuals with the LL genotype as measured naturalistically. By contrast, there was no support that ondansetron reduces drinking during the ASAEs or that sertraline reduces alcohol use in individuals who have SS/SL genotypes. We provide limited support that ondansetron may reduce drinking in nontreatment-seeking individuals with the LL genotype.

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OBJECTIVE: To identify community reentry needs, this study examined mental illness, substance dependence, and other correlates of reincarceration in an ethnically diverse, rural population of women prisoners. METHODS: A purposive, cross-sectional sample of 98 women in a New Mexico state prison completed structured interviews. Analyses examined associations of substance dependence, mental illness, lifetime trauma, and sociodemographic variables with previous incarceration. RESULTS: Eighty-five percent screened positive for substance dependence, 50% for current mental disorders, and 46% for both. Exposure to trauma was pervasive (100%), especially physical or sexual trauma (83%). In adjusted analyses, previous incarceration was associated with precarious housing before imprisonment (odds ratio [OR]=2.19, p=.038) and with having co-occurring mental illness and substance dependence (OR=2.68, p=.019). CONCLUSIONS: Findings support those of similar studies in urban areas and with other ethnic groups. Wraparound programs focusing on harm reduction, housing, and treatment and support services are needed for successful reentry of these underserved women.

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Preclinical and clinical studies show that the GABA(B) receptor agonist baclofen may represent a pharmacotherapy for alcohol dependence (AD). However, the mechanisms by which baclofen affects drinking are not well characterized; thus this pilot study investigated possible baclofen's biobehavioral mechanisms. The design was a double-blind controlled randomized human laboratory pilot study. Fourteen non-treatment seeking alcohol-dependent heavy drinking subjects received either baclofen 10mg t.i.d. or an active placebo (cyproheptadine 2mg t.i.d., to control for sedation) for a 7-day period. At day 8, participants performed an alcohol cue-reactivity (CR) followed by an alcohol self-administration (ASA). Additionally, we explored possible moderators that might guide future larger studies, i.e. anxiety, family history and onset of alcoholism, and D4 dopamine receptor (DRD4) and 5-HTTLPR polymorphisms. The main results were a significant effect of baclofen for increasing stimulation (p=.001) and sedation (p<.01). Furthermore, when drinking during the ASA and the 2 days before was analyzed as a composite variable, there was a significant effect of baclofen to reduce alcohol consumption (p<.01). As for the exploratory analyses, baclofen's effects to increase alcohol sedation and to reduce alcohol consumption were limited to those individuals with DRD4 ≥7 repeats (DRD4L). Yet, baclofen's effects on alcohol consumption were also moderated by 5-HTTLPR LL genotype. In conclusion, baclofen's ability to reduce alcohol drinking may be related to its effects on the biphasic effects of alcohol, but larger studies are needed to confirm these preliminary findings.

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Serotonin (5-HT) regulates important biological and psychological processes including mood, and may be associated with the development of several psychiatric disorders. An association between psychopathology and genes that regulate 5-HT neurotransmission is a robust area of research. Identification of the genes responsible for the predisposition, development, and pharmacological response of various psychiatric disorders is crucial to the advancement of our understanding of their underlying neurobiology. This review highlights research investigating 5-HT transporter (5-HTTLPR) polymorphism, because studies investigating the impact of the 5-HTTLPR polymorphism have demonstrated significant associations with many psychiatric disorders. Decreased transcriptional activity of the S allele ("risk allele") may be associated with a heightened amygdala response leading to anxiety-related personality traits, major depressive disorder, suicide attempts, and bipolar disorder. By contrast, increased transcriptional activity of the L allele is considered protective for depression but is also associated with completed suicide, nicotine dependence, and attention deficit hyperactivity disorder. For some disorders, such as post-traumatic stress disorder and major depressive disorder, the research suggests that treatment response may vary by allele (such as an enhanced response to serotonin specific reuptake inhibitors in patients with major depressive disorder and post-traumatic stress disorder with L alleles), and for alcohol dependence, the association and treatment for S or L alleles may vary with alcoholic subtype. While some studies suggest that 5-HTTLPR polymorphism can moderate the response to pharmacotherapy, the association between 5-HTTLPR alleles and therapeutic outcomes is inconsistent. The discovery of triallelic 5-HTTLPR alleles (L(A)/L(G)/S) may help to explain some of the conflicting results of many past association studies, while concurrently providing more meaningful data in the future. Studies assessing 5-HTTLPR as the solitary genetic factor contributing to the etiology of psychiatric disorders continue to face the challenges of statistically small effect sizes and limited replication.

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OBJECTIVE: Metadoxine is approved in Europe for alcohol intoxication and is also indicated for alcoholic liver disease (ALD). This study aims to investigate the use of metadoxine as a potential pharmacotherapy for alcohol dependence (AD). METHODS: This is a retrospective study of 94 outpatients with AD, who received metadoxine for alcohol intoxication and were assessed for alcohol consumption, craving [Visual Analog Scale (VAS)] and liver-related and alcohol-related biomarkers [aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl-transpeptidase, mean corpuscular volume]. RESULTS: Range of metadoxine dose was 500-2000 mg/day, with a mean dose of 1277(s.d.290) mg/day, and for a period of 2-42 days, with a mean period of 8.9(s.d.7.0) days. Follow-up data were available for 52 patients (55.3%); 35(67.3%) patients were completely abstinent. There was a significant decrease in drinks per week, even after substituting baseline drinking as follow-up data for dropouts (p < 0.001) and examining drinking pre-treatment and post-treatment for those who did not achieve abstinence (p < 0.001). There was a significant decrease in the VAS (p < 0.001) and a significant improvement in the AST/ALT ratio (p = 0.03). DISCUSSION: Despite important limitations, this study represents a further preliminary observation suggesting metadoxine as a novel alcohol pharmacotherapy, including in alcohol-dependent patients with ALD.

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Relapse to alcohol and other substances has generally been described by curves that resemble one another. However, these curves have been generated from the time to first use after a period of abstinence without regard to the movement of individuals into and out of drug use. Instead of measuring continuous abstinence, we considered post-treatment functioning as a more complicated phenomenon, describing how people move in and out of drinking states on a monthly basis over the course of a year. When we looked at time to first drink we observed the ubiquitous relapse curve. When we classified clients (N = 550) according to drinking state however, they frequently moved from one state to another with both abstinent and very heavy drinking states as being rather stable, and light or moderate drinking and heavy drinking being unstable. We found that clients with a family history of alcoholism were less likely to experience these unstable states. When we examined the distribution of cases crossed by the number of times clients switched states we found that a power function explained 83% of that relationship. Some of the remainder of the variance seems to be explained by the stable states of very heavy drinking and abstinence acting as attractors.

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OBJECTIVE: To increase understanding of the interrelationship between a patient's social network and patient drinking, the Important People and Activities (IPA) instrument was developed. To meet the aims of the COMBINE (Combining Medications and Behavioral Interventions) Study, the IPA was modified to create the Important People Inventory (IPI), which was used to measure the contextual influence of the patient's social network on patient outcomes and treatment effects. The aims of the present article were to describe the IPI and its differences from the IPA and to test the relationship of network support as measured by the IPI in predicting drinking during and following treatment. METHOD: Alcohol-dependent patients (N = 1,373) seeking outpatient treatment in the COMBINE randomized clinical trial were administered the IPI before treatment. Six network constructs were tested for predicting patient drinking. RESULTS: As unique effects, alcohol-specific support, as measured by network drinking and opposition to patient drinking, is predictive of patient abstinent days during and following treatment and heavy drinking days following treatment. Other measures of network support have variable relationships to patient drinking at different phases: Some are predictive of patient drinking during treatment but diminish, whereas others are unrelated to drinking during treatment but become increasingly predictive of drinking as time from treatment increases. CONCLUSIONS: The IPI is a useful instrument for describing network support of alcohol-use disorder patients entering treatment. Measures of alcohol-specific support are prognostic of drinking outcomes. The patient's network support should be systematically assessed prior to tailored treatment planning.

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BACKGROUND: We sought to determine predictors of drinking the month before and after beginning college, as well as changes in drinking between these two periods among adjudicated students. We conducted these analyses to inform individual and university-wide approaches to addressing underage drinking, particularly among the heaviest drinkers. METHODS: The sample consisted of 143 students entering college, adjudicated during their first semester, and interviewed during the same semester. The sample consisted of 43% women. Drinking data were collected through the Time-Line Follow-Back interview. RESULTS: The average number of drinking days (DD) during the first month of college was 7.0 (SD = 4.7), the average number of drinks per drinking day (DDD) was 7.4 (SD = 3.4), and the average volume of standard drink units consumed during this month was 56.3 (SD = 51.2). Students had volunteered for a two-year college facilitation study, and had been invited to participate after receiving a citation for violating university alcohol policies. Analyses consisted of nine backward elimination regression analyses with nine variables entered as predictors (one was a control variable). Age of first intoxication was related to every dependent measure. Men had a higher August DDD, September DDD, and September volume than women. Roommate drinking level was associated with September DDD and September volume. Out-of-state students had a lower August volume than in-state students. High school rank was inversely related to September drinking days. SAT score, declared major status, and fraternity/sorority status were not related to drinking according to these multivariate analyses. CONCLUSIONS: Results suggest that approaches to underage drinking for adjudicated students may need to be tailored according to age of first intoxication. Results also suggest the drinking level of the heaviest drinking roommate may moderate individual level interventions. Further, interventions applied to an entire dorm room may prove efficacious. Results also suggest that high school rank, rather than SAT scores, should be used as college entry criteria to yield a drier incoming class. Results may not generalize to non-adjudicated students.

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