Smoking Cessation Treatment for Methadone Maintenance Patients

NCT01027754 | Completed Phase 4 Results DMC

• 2 other identifiers: 2008-537UL1RR025750
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Substance-Related Disorders

Keywords

methadone maintenance

Outcome Measures

Primary Outcomes (1)

• Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.

  Week 12

Secondary Outcomes (14)

• Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.

  Week 24

• Number of Counseling Visits Completed

  End of 12 week intervention period

• Number of Study Visits Completed

  24 weeks

• 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.

  Weeks 2, 4, 8, 12, and 24

• Number of Cigarettes Smoked Per Day

  Weeks 2, 4, 8, 12, and 24

Study Arms (2)

Varenicline

EXPERIMENTAL

Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12

Drug: Varenicline

Placebo

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

Drug: Placebo

Interventions

Varenicline DRUG

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

Also known as: Chantix

Varenicline

Placebo DRUG

Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily

Also known as: Matched capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10467, United States

Location

Related Publications (2)

• 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.

  PMID: 37142273 DERIVED

• Nahvi S, Ning Y, Segal KS, Richter KP, Arnsten JH. Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction. 2014 Sep;109(9):1554-63. doi: 10.1111/add.12631. Epub 2014 Jun 27.

  PMID: 24862167 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Substance-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Self-reported smoking reduction could not be biochemically validated. We did not analyze changes in drug use over time. Sample size limited power to detect rare psychiatric events. Findings may not be generalizable to other populations.

Results Point of Contact

• Title: Dr. Shadi Nahvi
• Organization: Albert Einstein College of Medicine/Montefiore Medical Center

SNAHVI@montefiore.org

718 920 5379

Study Officials

• Shadi Nahvi, M.D., M.S.

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 26, 2021
• Results First Posted: January 29, 2020

Record last verified: 2021-05

Locations

US (1)