Smoking Cessation Treatment for Methadone Maintenance Patients

A

Albert Einstein College of Medicine

Status and phase

Completed
Phase 4

Conditions

Substance-Related Disorders
Smoking Cessation

Treatments

Drug: Placebo
Drug: Varenicline

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01027754
2008-537
UL1RR025750 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

112 participants in 2 patient groups, including a placebo group

Varenicline
Experimental group
Description:
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Treatment:
Drug: Varenicline
Placebo
Placebo Comparator group
Description:
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems