Varenicline for Co-occurring Cannabis and Tobacco Use

NCT04595318 | Completed Phase 4 Results FDA Drug

• 4 other identifiers: 2010-279-12R25GM104547K23DA025736R25DA023021
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cannabis Dependence; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Enrollment Rate

  Percentage of the eleven eligible subjects willing to participate

  Baseline

Secondary Outcomes (13)

• Retention Rate

  Week 8

• Overall Medication Adherence

  Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group)

• 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)

• 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)

• Cannabis Craving

  Week 4 and Week 8

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.

Also known as: SCC first, then SCC+VT

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

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

Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.

Also known as: SCC+VT first, then SCC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable medical or psychiatric illness

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

MeSH Terms

Conditions

Marijuana Abuse; Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Shadi Nahvi
• Organization: Montefiore Health System

snahvi@montefiore.org

718 920 5379

Study Officials

• Shadi Nahvi

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: October 20, 2020
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share