Smoking Cessation Treatment for Methadone Maintenance Patients

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Smoking Cessation
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

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

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline; 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; 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; Other Names: Chantix
Placebo Comparator: Placebo; 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; Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily; Other Names: Matched capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.		Week 24
Number of Counseling Visits Completed	Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.	End of 12 week intervention period
Number of Study Visits Completed	Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.	24 weeks
7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.	Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™).	Weeks 2, 4, 8, 12, and 24
Number of Cigarettes Smoked Per Day		Weeks 2, 4, 8, 12, and 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours		Weeks 2, 4, 8, 12, and 24
Confidence in Quitting Smoking (1-10 Scale)	Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).	Weeks 2, 4, 8, 12, and 24
Importance of Quitting Smoking (1-10 Scale)	Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).	Weeks 2, 4, 8, 12, and 24
Adverse Medication Effects		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Shadi Nahvi, M.D., M.S., Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 7, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: methadone maintenance
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2008-537; UL1RR025750 (U.S. NIH Grant/Contract)