Varenicline for Co-occurring Cannabis and Tobacco Use
- Conditions
- Tobacco DependenceCannabis Dependence
- Interventions
- Drug: Standard clinical care first, followed by standard clinical care and vareniclineDrug: Standard clinical care and varenicline first, followed by standard clinical care
- Registration Number
- NCT04595318
- Lead Sponsor
- Albert Einstein College of Medicine
- Brief Summary
Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance abuse 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. Participants were recruited from an urban, outpatient substance abuse treatment program that offers both intensive behavioral counseling and medication-assisted treatment (MAT) for opioid use disorder. The investigators selected these clinical sites because the investigators have successfully recruited and retained participants from these sites in prior clinical trials, and anticipated that they would find a high prevalence of persons with frequent cannabis use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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
- Unstable medical or psychiatric illness
- Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard clinical care first, followed by standard clinical care and varenicline Standard clinical care first, followed by standard clinical care and varenicline Four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). This is followed by four weeks of SCC plus varenicline treatment (SCC and VT). Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Standard clinical care and varenicline first, followed by standard clinical care Standard clinical care and varenicline first, followed by standard clinical care Four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. This is followed by four weeks of SCC in an outpatient substance use disorder treatment program, as described above.
- Primary Outcome Measures
Name Time Method Enrollment Rate Baseline Percentage of the eleven eligible subjects willing to participate
- Secondary Outcome Measures
Name Time Method Retention Rate Week 8 Retention rate was determined by the percentage of participants who completed all study visits.
Overall Medication Adherence Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group) Overall medication adherence was calculated as a percentage based on the number of pills prescribed during the study, corrected for the number of pills returned, divided by the period (in days), and multiplied by 100. An aggregate percentage of pills was calculated and reported for all seven study participants.
Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group) The number of participants with a self-reported adverse event of upset stomach was determined using a structured questionnaire of common varenicline symptoms
Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group) The number of participants with self-reported Treatment-Emergent symptoms of major depressive disorder was determined using the MINI International Neuropsychiatric Interview (M.I.N.I), a short structured diagnostic interview tool used to assess DSM-IV and ICD-10 psychiatric disorders
Cannabis Craving Week 4 and Week 8 Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF). The MCQ-SF is a valid and reliable, self-report instrument with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving.
Cannabis Withdrawal Week 4 and Week 8 Cannabis withdrawal was measured by the 15-item version of the Marijuana Withdrawal Checklist (MWC). Participants rated each symptom experienced during their most recent period of marijuana abstinence, based on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A total MWC score was obtained by summing the responses. Possible total scoring ranges from 0 - 45, with 0 signifying no withdrawal symptoms and 45 signifying the most severe withdrawal symptoms.
Quantity of Cannabis Use Week 4 and Week 8 The quantity of cannabis use over the prior 14-day period was measured using the Timeline Follow-Back (TLFB) method. TLFS is a method in which participants used a physical calendar to quantify the number of days over a specified period of time (in this study 14 days) during which cannabis was used. An aggregate value for percentage of days of cannabis use was calculated by tabulating the total number of days cannabis was used by all study participants over the prior 14-day period and dividing by the total number of calendar days over this period across the 7 participants (i.e., 14x7=98).
Frequency of Cannabis Use Week 4 and Week 8 The frequency of cannabis use per day was evaluated over the prior 14-day period using the Timeline Follow-Back method (TLFB), a method in which participants used a physical calendar to self-report the number times per days cannabis was used.
Number of Cigarettes Smoked Per Day Week 4 and Week 8 The number of cigarettes smoked per day was measured using Timeline Follow-Back (TLFB). TLFB is a method in which participants used a physical calendar to self-report the number of cigarettes smoked per day over the prior 14-day period in order to evaluate ongoing tobacco usage.
Number of Participants With Toxicology-verified Cannabis Abstinence Week 4 and Week 8 The number of participants with Toxicology-verified cannabis abstinence was determined by applying the TLFB method and then biochemically confirming the number of participants with a urine tetrahydrocannabinol (THC) levels less than 50 ng/ml.
Number of Participants With Biochemically-verified Tobacco Abstinence Week 4 and Week 8 The number of participants with biochemically-verified tobacco abstinence was determined by applying the TLFB method and then biochemically verified by measuring participant levels of expired carbon monoxide \< 8 parts per million (CO \< 8ppm). The Bedfont Smokerlyzer carbon monoxide monitor was used in the analysis.
Mean Expired Carbon Monoxide Week 4 and Week 8 Mean expired carbon monoxide (CO) per participant was measured using the Bedfont Smokerlyzer carbon monoxide monitor. Results reported in mean parts per million (ppm)
Number of Participants With Treatment-Emergent Suicidal Ideation Events Week 4 and Week 8 The number of participants with treatment-emergent suicidal ideation events was determined using the Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime as well as during the past 3 months. An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions to the final three questions indicates high-risk.