Phase 4
N=7
Varenicline for Co-occurring Cannabis and Tobacco Use
Cannabis Dependence · Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT04595318 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Enrollment Rate — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standard clinical care first, followed by standard clinical care and varenicline (Drug); Standard clinical care and varenicline first, followed by standard clinical care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
7 | — |
| SECONDARY Retention Rate |
7 | — |
| SECONDARY Overall Medication Adherence |
62 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach |
5 | — |
| SECONDARY Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder |
1 | — |
| SECONDARY Cannabis Craving |
34; 35 | — |
| SECONDARY Cannabis Withdrawal |
4; 4 | — |
| SECONDARY Quantity of Cannabis Use |
82; 60 | — |
| SECONDARY Frequency of Cannabis Use |
3; 2 | — |
| SECONDARY Number of Cigarettes Smoked Per Day |
5; 5 | — |
| SECONDARY Number of Participants With Toxicology-verified Cannabis Abstinence |
1; 1 | — |
| SECONDARY Number of Participants With Biochemically-verified Tobacco Abstinence |
2; 1 | — |
| SECONDARY Mean Expired Carbon Monoxide |
13; 14 | — |
| SECONDARY Number of Participants With Treatment-Emergent Suicidal Ideation Events |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04595318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.