Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

NCT ID: NCT01378858

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-07-31

Brief Summary

This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

Detailed Description

There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence.

Conditions

Tobacco Use Disorder; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Varenicline treatment as usual (TAU)

Subjects in the TAU arm will self administer varenicline for 12 weeks.

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.

Varenicline directly observed therapy

Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.

Interventions

Varenicline

Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Chantix

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• English speaking
• Smoked at least 100 cigarettes/lifetime
• Smoke 5 or more cigarettes per day
• Interested in quitting smoking (preparation or contemplation stage of change)
• Enrolled in Einstein/Montefiore methadone program for 12 weeks or more
• Receiving methadone in clinic three, four, five or six times per week
• No more than 2 methadone clinic misses in prior 14 days
• Agree to use contraception for the duration of the trial (among women with reproductive potential)
• Willing to participate in all study components
• Able to provide informed consent

Exclusion Criteria

• Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
• Psychiatric instability
• Women who are pregnant, breastfeeding, or contemplating pregnancy
• Creatinine clearance <30 mL/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Shadi Nahvi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shadi Nahvi, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

References

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction. 2021 Apr;116(4):902-913. doi: 10.1111/add.15240. Epub 2020 Oct 13.

Reference Type: DERIVED

PMID: 32857445 (View on PubMed)

Nahvi S, Segal KS, Litwin AH, Arnsten JH. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addict Sci Clin Pract. 2014 Jun 13;9(1):9. doi: 10.1186/1940-0640-9-9.

Reference Type: DERIVED

PMID: 24928218 (View on PubMed)

Other Identifiers

K23DA025736

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-279

Identifier Type: -

Identifier Source: org_study_id