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In a randomized trial involving participants with methamphetamine use disorder, the response among those who received bupropion and naltrexone was 11 percentage points higher than that among participants who received placebo. Adverse events included gastrointestinal disorders.

RationaleDepression is common among individuals with cannabis use disorder (CUD), particularly individuals who present to CUD treatment. Treatments that consider this comorbidity are essential.ObjectivesThe goal of this secondary analysis was to examine whether N-acetylcysteine (NAC) reduced depressive symptoms among adults (age 18–50) with CUD (N = 302) and whether the effect of NAC on cannabis cessation varied as a result of baseline levels of depression. Bidirectional associations between cannabis use amount and depression were also examined.MethodsData for this secondary analysis were from a National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) multi-site clinical trial for CUD. Adults with CUD (N = 302) were randomized to receive 2400 mg of NAC daily or matched placebo for 12 weeks. All participants received abstinence-based contingency management. Cannabis quantity was measured by self-report, and weekly urinary cannabinoid levels (11-nor-9-carboxy-Δ9-tetrahydrocannabinol) confirmed abstinence. Depressive symptoms were measured by the Hospital Anxiety and Depression Scale.ResultsDepressive symptoms did not differ between the NAC and placebo groups during treatment. There was no significant interaction between treatment and baseline depression predicting cannabis abstinence during treatment. Higher baseline depression was associated with decreased abstinence throughout treatment and a significant gender interaction suggested that this may be particularly true for females. Cross-lagged panel models suggested that depressive symptoms preceded increased cannabis use amounts (in grams) during the subsequent month. The reverse pathway was not significant (i.e., greater cannabis use preceding depressive symptoms).ConclusionsResults from this study suggest that depression may be a risk factor for poor CUD treatment outcome and therefore should be addressed in the context of treatment. However, results do not support the use of NAC to concurrently treat co-occurring depressive symptoms and CUD in adults.Trial RegistrationClinicaltrials.gov: NCT01675661

Background Cocaine and methamphetamine use disorders (CcUD/MtUD) have serious public health, medical, and psychiatric consequences. Yet, there are no U.S. Food and Drug Administration (FDA) approved treatments available. The STIMULUS study is a multi-site trial, sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN), that aims to investigate the feasibility and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for moderate to severe CcUD/MtUD. Methods The study is a double-blind, sham-controlled trial seeking to recruit 160 participants with a current moderate to severe CcUD or MtUD diagnosis, randomized to receive active rTMS (10-Hz stimulation at 120% motor threshold over the left dorsolateral prefrontal cortex) or sham. Feasibility is assessed by a target of at least 20 treatment sessions administered within an 8-week period. Additionally, the study aims to evaluate the efficacy of rTMS in reducing stimulant use and craving, the impact of rTMS on mood, anxiety, sleep, and other measures, and the utility of electroencephalography as a treatment response biomarker. Discussion Studies exploring rTMS for stimulant use disorders remain limited by small sample sizes, as well as great heterogeneity in defined study population, treatment parameters, retention in treatment, and number of sessions. In this paper, we highlight key study design decisions, such as safety, sham procedure, and schedule flexibility. Conclusion We hope that the data collected will lay the groundwork for a robust randomized controlled trial of rTMS as a therapeutic intervention for individuals with CcUD/MtUD. Trial registration http://www.ClinicalTrials.gov . Identifier: NCT04907357. Trial data set https://clinicaltrials.gov/study/NCT04907357?tab=table . Protocol Version 7.0, 11/10/2023.

Objective: Psychostimulants are effective treatments for attention-deficit/hyperactivity disorder (ADHD) but may be associated with euphoric effects, misuse/diversion, and adverse effects. These risks are perceived by some clinicians to be greater in substance-abusing adolescents relative to non–substance-abusing adults. The present study evaluates the subjective effects, misuse/diversion, and adverse effects associated with the use of osmotic-release oral system methylphenidate (OROS-MPH), relative to placebo, for treating ADHD in adolescents with a substance use disorder (SUD) as a function of substance use severity and compared these risks with those associated with the treatment of ADHD in adults without a non-nicotine SUD. Method: Datasets from two randomized placebo-controlled trials of OROS-MPH for treating ADHD, one conducted with 303 adolescents (13–18) with at least one non-nicotine SUD and one with 255 adult smokers (18–55), were analyzed. Outcome measures included the Massachusetts General Hospital Liking Scale, self-reported medication compliance, pill counts, and adverse events (AEs). Results: Euphoric effects and misuse/diversion of OROS-MPH were not significantly affected by substance use severity. The euphoric effects of OROS-MPH did not significantly differ between the adolescent and adult samples. Adults rated OROS-MPH as more effective in treating ADHD, whereas adolescents reported feeling more depressed when taking OROS-MPH. The adolescents lost more pills relative to the adults regardless of treatment condition, which suggests the importance of careful medication monitoring. Higher baseline use of alcohol and cannabis was associated with an increased risk of experiencing a treatment-related AE in OROS-MPH, but baseline use did not increase the risk of serious AEs or of any particular category of AE and the adolescents did not experience more treatment-related AEs relative to the adults. Conclusions: With good monitoring, and in the context of substance abuse treatment, OROS-MPH can be safely used in adolescents with an SUD despite non-abstinence.

Post-traumatic stress disorder (PTSD) is commonly comorbid with other psychiatric disorders, including substance use disorders. In spite of this, pharmacologic treatment trials for PTSD often exclude individuals with significant psychiatric comorbidity. This study is a post hoc analysis of a 12-week double-blind placebo-controlled trial investigating sertraline in the treatment of patients with comorbid PTSD and an alcohol use disorder. Individuals with additional anxiety and affective disorders were included. Patients (N = 93) were stratified into four groups depending on presence or absence of additional anxiety or depressive disorders and evaluated for the effects of comorbidity on PTSD symptoms, depressive symptoms, and drinking behaviors. We hypothesized that additional comorbidity would be associated with poorer outcomes. Patients in all four subgroups showed marked and clinically significant improvement in alcohol drinking behaviors over the course of the study. For the entire sample, over the course of the 12 weeks, mean drinks per drinking day fell from 13.0 ± 8.4 (SD) to 3.0 ± 5.0 (SD); t = 10.2, df = 92, P < .000. There were, however, no significant differences among groups. Patients in all four groups showed moderate improvement in Hamilton Depression Rating Scale (HAMD) scores and Clinician-Administered PTSD scale (CAPS) scores at endpoint. For the entire sample, mean CAPS scores fell from 59.3 ± 19.4 (SD) to 40.8 ± 26.0, t = 8.9, df = 92, P < .000. Mean HAMD scores fell from 17. 9 ± 6.7 (SD) at baseline to 11.8 ± 9.4 (SD) at endpoint; t = 6.7, df = 92, P < .000. There were, however, no significant differences among groups for change in HAM-D or CAPS scores. Hence, contrary to our hypothesis, having additional anxiety or mood disorder comorbidity did not decrease treatment response in individuals with comorbid PTSD and an alcohol use disorder.

Addiction to alcohol or other drugs (AODs) is a complex problem determined by multiple factors, including psychological and physiological components. Stress is considered a major contributor to the initiation and continuation of AOD use as well as to relapse. Many studies that have demonstrated an association between AOD use and stress have been unable to establish a causal relationship between the two. However, stress and the body's response to it most likely play a role in the vulnerability to initial AOD use, initiation of AOD abuse treatment, and relapse in recovering AOD users. This relationship probably is mediated, at least in part, by common neurochemical systems, such as the serotonin, dopamine, and opiate peptide systems, as well as the hypothalamic-pituitary-adrenal (HPA) axis. Further exploration of these connections should lead to important pharmacological developments in the prevention and treatment of AOD abuse. Studies indicate that treatment techniques which foster coping skills, problem-solving skills, and social support play a pivotal role in successful treatment. In the future, individualized treatment approaches that emphasize stress management strategies in those patients in whom a clear connection between stress and relapse exists will become particularly important.

Substance abuse treatment organizations are universally faced with the problem of co-occurring psychiatric disorders among the clients they serve. A first step is assessment of such comorbid conditions; however, the time constraints in front-line substance abuse treatment organizations make extensive clinical assessments almost impossible. The development and validation of a brief screening tool for psychiatric disorders in individuals with substance use disorders (SUDs) could have enormous implications for clinical practice. We assessed the performance characteristics of the Psychiatric Diagnostic Screening Questionnaire (PDSQ) and the Conners' Adult ADHD Rating Scale (CAARS) against the Structured Clinical Interview for DSM-IV (SCID-IV) in 120 patients admitted to SUD treatment. Patients were randomly assigned to receive either the SCID or PDSQ. In general, the PDSQ and CAARS performed well. There were no statistically significant performance differences by order of administration, gender, or drug use in past month. For the GAD subscale, Caucasian patients had higher levels of agreement than non-Caucasian patients.

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.

Abstract Approximately 1.5 million Americans seek treatment for alcoholism annually. Malnutrition is frequently observed in the alcoholic population due to several factors, including poor dietary intake, alcohol-associated gastrointestinal problems, decreased nutrient absorption and enhanced excretion of trace elements. The administration of multivitamins with minerals and folic acid is commonplace. The present paper reviews basic nutrient deficits commonly encountered in alcoholic individuals and describes the rationale and basic guidelines for oral replacement therapy.