Phase 4
N=112
Smoking Cessation Treatment for Methadone Maintenance Patients
Smoking Cessation · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01027754 ↗Enrolled (actual)
112
Serious AEs
4.5%
Results posted
Jan 2020
Primary outcome: Primary: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. — 6; 0 participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. |
3; 0 | 0.24 |
| SECONDARY Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. |
3; 0 | 0.24 |
| SECONDARY Number of Counseling Visits Completed |
1.96; 1.85 | — |
| SECONDARY Number of Study Visits Completed |
5.72; 5.36 | — |
| SECONDARY 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine. |
— | — |
| SECONDARY Number of Cigarettes Smoked Per Day |
3; 6; 2; 5; 3; 5 | — |
| SECONDARY Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours |
33; 25; 35; 27; 37; 32 | — |
| SECONDARY Confidence in Quitting Smoking (1-10 Scale) |
8; 8; 9; 8; 9; 9 | — |
| SECONDARY Importance of Quitting Smoking (1-10 Scale) |
10; 10; 10; 10; 10; 10 | — |
| SECONDARY Adverse Medication Effects |
18; 14; 27; 23; 29; 18 | — |
| SECONDARY Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory |
9; 11; 4; 7; 6; 7 | 0.15 |
| SECONDARY Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview |
0; 2; 0; 0; 1; 0 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01027754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.