Smoking Cessation Treatment for Methadone Maintenance Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shadi Nahvi, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01027754
First received: December 7, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Substance-Related Disorders
Drug: Varenicline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smoking Cessation Treatment for Methadone Maintenance Patients

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Biochemically verified abstinence verified with expired carbon monoxide (CO) < 8 p.p.m. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemically verified abstinence verified with expired carbon monoxide (CO)​ < 8 p.p.m. [ Time Frame: Weeks 2, 4, 8, and 24 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 7-day point prevalence abstinence at 12 weeks (verified by salivary cotinine). [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Number of cigarettes smoked per day [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Quit attempts lasting ≥ 24 hours [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Confidence in quitting smoking (1-10 scale) [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Importance of quitting smoking (1-10 scale) [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Adverse medication effects [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: Yes ]
  • Psychiatric symptoms assessed by the Brief Symptom Inventory [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: Yes ]
  • Psychiatric disease assessed by the Mini-International Neuropsychiatric Interview [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 134
Study Start Date: August 2009
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Matched capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027754

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Shadi Nahvi, M.D., M.S. Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Shadi Nahvi, Study Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01027754     History of Changes
Other Study ID Numbers: 2008-537
Study First Received: December 7, 2009
Last Updated: June 16, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
methadone maintenance

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Varenicline
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014