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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
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
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, United States
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 12
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 24
Number of Counseling Visits Completed
Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.
Time frame: 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.
Time frame: 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™).
Time frame: Weeks 2, 4, 8, 12, and 24
Number of Cigarettes Smoked Per Day
Time frame: Weeks 2, 4, 8, 12, and 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
Time frame: 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).
Time frame: 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).
Time frame: Weeks 2, 4, 8, 12, and 24
Adverse Medication Effects
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
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