Clinical trial NCT04595318: Varenicline for Co-occurring Cannabis and Tobacco Use
Official title: Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cannabis Dependence
Tobacco Dependence
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-10-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.

Detailed description: Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (MOUD). Participants were randomized to receive either SCC or SCC and varenicline first and then were crossed over to receive the opposite intervention. The study consisted of two 4-week treatment periods with no washout period. Outcomes are reported in pooled analyses of all participants in each treatment phase.

Eligibility criteria: Inclusion Criteria:

* Able to speak English
* Uses cannabis at least 5 days in the past 7 days
* Current or former tobacco smoker
* Has not taken varenicline in the past 30 days
* Not pregnant, trying to conceive or breastfeeding
* Able to provide informed consent
* Test positive for cannabinoids by urine toxicology

Exclusion Criteria:

* Unstable medical or psychiatric illness
* Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.

Primary outcomes:
measure: Enrollment Rate
timeFrame: Baseline
Secondary outcomes:
measure: Retention Rate
timeFrame: Week 8
measure: Overall Medication Adherence
timeFrame: Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group)
measure: Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach
timeFrame: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
measure: Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder
timeFrame: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
measure: Cannabis Craving
timeFrame: Week 4 and Week 8
measure: Cannabis Withdrawal
timeFrame: Week 4 and Week 8
measure: Quantity of Cannabis Use
timeFrame: Week 4 and Week 8
measure: Frequency of Cannabis Use
timeFrame: Week 4 and Week 8
measure: Number of Cigarettes Smoked Per Day
timeFrame: Week 4 and Week 8
measure: Number of Participants With Toxicology-verified Cannabis Abstinence
timeFrame: Week 4 and Week 8
measure: Number of Participants With Biochemically-verified Tobacco Abstinence
timeFrame: Week 4 and Week 8
measure: Mean Expired Carbon Monoxide
timeFrame: Week 4 and Week 8
measure: Number of Participants With Treatment-Emergent Suicidal Ideation Events
timeFrame: Week 4 and Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Shadi Nahvi
role: PRINCIPAL_INVESTIGATOR
References: