Clinical trial · Interventional
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
NCT00790569CI-TRIAL-00033213completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nicotine | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| varenicline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- interventionNames
- Drug: varenicline
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- interventionNames
- Other: placebo
- type
- ACTIVE_COMPARATOR
- label
- Arm III
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
INCLUSION CRITERIA * Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months) * Interested in quitting smoking * Willing to set a quit date 7 days after baseline assessment * Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions: * Codac, Inc. (with two independent sites) * Addiction Recovery Institute * Center for Treatment and Recovery * Discovery House * Has received methadone for at least the past month EXCLUSION CRITERIA * Pregnant or nursing (Must have negative pregnancy test) * Non-English speaking * No personal telephone or does not live close to a relative or neighbor with a telephone * Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review * Unvailable for this study for the next 12 months * Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension) * Active skin condition (e.g., psoriasis) * History of skin allergy * History of a suicide attempt * Working as pilots, drivers, or operators of heavy machinery PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent insulin or blood thinners * No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
References
Publications (4)
- BACKGROUNDStein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14. PMID 23953658
- DERIVEDLivingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. PMID 37142273
- DERIVEDde Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764. PMID 24821357
- DERIVEDCaviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28. PMID 23199641