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Completed

NCT Number: NCT01027754

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.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Chantix

Placebo

Drug

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

Other names: Matched capsules

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 24

  2. Number of Counseling Visits Completed

    Time frame: End of 12 week intervention period

    Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.

  3. Number of Study Visits Completed

    Time frame: 24 weeks

    Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.

  4. 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.

    Time frame: Weeks 2, 4, 8, 12, and 24

    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™).

  5. Number of Cigarettes Smoked Per Day

    Time frame: Weeks 2, 4, 8, 12, and 24

  6. Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours

    Time frame: Weeks 2, 4, 8, 12, and 24

  7. Confidence in Quitting Smoking (1-10 Scale)

    Time frame: Weeks 2, 4, 8, 12, and 24

    Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).

  8. Importance of Quitting Smoking (1-10 Scale)

    Time frame: Weeks 2, 4, 8, 12, and 24

    Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).

  9. Adverse Medication Effects

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

  10. Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

  11. Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

  12. Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

  13. Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

  14. Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview

    Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 9, 2009
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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