Varenicline for Co-occurring Cannabis and Tobacco Use

Albert Einstein College of Medicine

Status and phase: Completed; Phase 4

Conditions: Tobacco Dependence; Cannabis Dependence

Treatments: Drug: Standard clinical care and varenicline first, followed by standard clinical care; Drug: Standard clinical care first, followed by standard clinical care and varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04595318

R25DA023021 (U.S. NIH Grant/Contract)

2010-279-12

R25GM104547 (U.S. NIH Grant/Contract)

K23DA025736 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

7 participants in 2 patient groups

Standard clinical care first, followed by standard clinical care and varenicline

Experimental group

Description:

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.

Treatment:

Drug: Standard clinical care first, followed by standard clinical care and varenicline

Standard clinical care and varenicline first, followed by standard clinical care

Experimental group

Description:

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.

Treatment:

Drug: Standard clinical care and varenicline first, followed by standard clinical care