Overview

This trial is active, not recruiting.

Conditions smoking cessation, substance-related disorders
Treatments varenicline, placebo
Phase phase 4
Sponsor Albert Einstein College of Medicine of Yeshiva University
Start date August 2009
End date August 2014
Trial size 134 participants
Trial identifier NCT01027754, 2008-537

Summary

Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
varenicline Chantix
Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
(Placebo Comparator)
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
placebo Matched capsules
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily

Primary Outcomes

Measure
Biochemically verified abstinence verified with expired carbon monoxide (CO) < 8 p.p.m.
time frame: 12 weeks

Secondary Outcomes

Measure
Biochemically verified abstinence verified with expired carbon monoxide (CO)​ < 8 p.p.m.
time frame: Weeks 2, 4, 8, and 24
Intervention Feasibility (evaluation of study participation, counseling contacts, adherence to medication therapy, and participant satisfaction.)
time frame: Study participation, counseling contacts, and participant satisfaction at Week 12; medication adherence at Weeks 2, 4, 8, and 12.
7-day point prevalence abstinence at 12 weeks (verified by salivary cotinine).
time frame: Weeks 2, 4, 8, 12, and 24
Number of cigarettes smoked per day
time frame: Weeks 2, 4, 8, 12, and 24
Quit attempts lasting ≥ 24 hours
time frame: Weeks 2, 4, 8, 12, and 24
Confidence in quitting smoking (1-10 scale)
time frame: Weeks 2, 4, 8, 12, and 24
Importance of quitting smoking (1-10 scale)
time frame: Weeks 2, 4, 8, 12, and 24
Adverse medication effects
time frame: Weeks 2, 4, 8, 12, and 24
Psychiatric symptoms assessed by the Brief Symptom Inventory
time frame: Weeks 2, 4, 8, 12, and 24
Psychiatric disease assessed by the Mini-International Neuropsychiatric Interview
time frame: Weeks 2, 4, 8, 12, and 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 or older - English speaking - Smoked at least 100 cigarettes/lifetime - Smokes 5 or more cigarettes per day - Interested in quitting smoking (preparation or contemplation state of change) - Enrolled in Einstein/Montefiore methadone program for 3 or more months - Stable methadone dose for 2 weeks - Agree to use contraception throughout 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 less than 30 mL/min

Additional Information

Official title Smoking Cessation Treatment for Methadone Maintenance Patients
Principal investigator Shadi Nahvi, M.D., M.S.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.