Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Medication Adherence
• Intervention / Treatment: Drug: Varenicline

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline treatment as usual (TAU); Subjects in the TAU arm will self administer varenicline for 12 weeks.	Drug: Varenicline; Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.; Other Names: Chantix
Experimental: 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.	Drug: Varenicline; Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.; Other Names: Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Varenicline Adherence as Measured by Pill Count	Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure	Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks	Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m., missing = smoking	Week 12 of treatment
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks	Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m.	24 weeks

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Shadi Nahvi, M.D., M.S., Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Smoking; Methadone; medication adherence; Substance-Related Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2010-279; K23DA025736 (U.S. NIH Grant/Contract)