N-acetylcysteine for smoking cessation among dual users of tobacco and cannabis: Protocol and rationale for a randomized controlled trial.

BACKGROUND: Tobacco and cannabis co-use is a growing public health problem. The synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared environmental cues reinforcing use may make tobacco smoking cessation more difficult. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use. NAC's potential efficacy in treating addiction may be attributable to its central nervous system effects in reducing excessive glutamatergic activity, oxidative stress, and inflammation. To date, no RCT has examined NAC for smoking cessation among dual users of tobacco and cannabis. METHOD: In a double-blind, placebo-controlled RCT, we will examine NAC for smoking cessation among dual users of tobacco and cannabis. Sixty adult cigarette-cannabis co-users are randomized to receive NAC 3600 mg per day or placebo over 8 weeks. Participants in both groups receive 8 weekly cognitive behavioral therapy sessions addressing smoking cessation and cannabis reduction. Outcomes are assessed at Weeks 0, 4, 8, and 12. Primary aims are to determine NAC's efficacy in decreasing cigarette craving, nicotine dependence, and use; and cannabis craving and use. Exploratory aims include examination of changes in neurocognition with NAC and their potential mediational effects on cigarette and cannabis use outcomes. CONCLUSION: Results will inform smoking cessation treatment among dual users of tobacco and cannabis. CLINICALTRIALS: gov Identifier: NCT04627922.

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial.

BACKGROUND: Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment. METHODS: A multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms. CONCLUSION: This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04648228.

E-Cigarette Use and Perceptions Among Veterans Receiving Outpatient Treatment in Veterans Affairs Substance Use and Mental Health Clinics.

INTRODUCTION: Individuals with substance use disorders and/or mental health (MH) conditions have higher rates of cigarette smoking than the general population. Electronic nicotine delivery systems (ENDS) while gaining popularity pose health risks. Herein we investigate risk perceptions and attitudes toward e-cigarettes in military Veterans with MH conditions. MATERIALS AND METHODS: Participants included U.S. Veterans receiving services from Veterans Administration MH/substance use disorder clinics in the San Francisco Bay Area (N = 98; 95% male, 44% White, 34% Black/African American), who completed a survey on smoking and health. Results compare attitudes and perceptions regarding e-cigarette use between ever and never e-cigarette users. The study was reviewed by the Institutional Review Board at both the Veterans Administration and University. RESULTS: Most respondents reported being current/past cigarette smokers (91%) and over a third reported having ever used an e-cigarette (38%). Most believed that e-cigarettes are not safe, are potentially dangerous, are potentially addictive if they use every day and are tempting and appealing to youth. Fifty-one percent of ever-users agreed with a statement that e-cigarettes can help people quit smoking regular cigarettes completely, and there was a significant difference in this belief when comparing them with never-users (23% agreed); χ2 = 9.259, P = 0.010. CONCLUSIONS: Proportion of e-cigarette use in this Veteran sample is greater than the general population. We observed high risk perception about e-cigarettes among all respondents and differences in perceived helpfulness of e-cigarettes for quitting in ever-users versus never-users in this sample. More consistent assessment of tobacco use among Veterans, with inclusion of ENDS use, would help inform prevention and treatment priorities, especially as information on health impacts of ENDS surfaces.