Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shadi Nahvi, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01378858
First received: June 21, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Tobacco Use Disorder
Medication Adherence
Behavioral: Varenicline treatment as usual or directly observed therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Varenicline 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:
  • Varenicline adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Adherence will be measured by pill count and self report

  • Tobacco Use Measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Reduction in number of cigarettes per day; time to first daily cigarette; ≥24 hour quit attempts; and biochemically verified 7-day point prevalence abstinence at 24 weeks.


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline treatment as usual (TAU)
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Behavioral: Varenicline treatment as usual or directly observed therapy
Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
Other Name: 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.
Behavioral: Varenicline treatment as usual or directly observed therapy
Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
Other Name: Chantix

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.

  Eligibility

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

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
  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: NCT01378858

Contacts
Contact: Shadi Nahvi, M.D., M.S. (718) 944-3844 snahvi@dosa.aecom.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University Recruiting
New York, New York, United States, 10467
Contact: Shadi Nahvi, MD, MS    718-944-3844      
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 by Albert Einstein College of Medicine of Yeshiva University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shadi Nahvi, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01378858     History of Changes
Other Study ID Numbers: 2010-279, K23DA025736
Study First Received: June 21, 2011
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:
Smoking
Substance-Related Disorders
medication adherence
Methadone

Additional relevant MeSH terms:
Tobacco Use Disorder
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 18, 2014