TriangleNCT00790569 · REGISTRY CONDITION SEARCH
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2018-06-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Self- Reported 7-day Abstinence
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Self-reported 7-day Abstinence
CO-confirmed 7-day Abstinence
Change in Smoking Urges
Withdrawal Symptoms
Retention in Methadone Maintenance
Methadone Dose Changes
Use of Illicit Drugs as Measured by Urine Toxicologies
Reinforcing Effects of Smoking
Change in Cigarettes Per Day
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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.
- intervention Names
- Drug: varenicline
- label
- Arm I
- type
- EXPERIMENTAL
- 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.
- intervention Names
- Other: placebo
- label
- Arm II
- type
- PLACEBO_COMPARATOR
- description
- Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
- intervention Names
- Drug: nicotine
- label
- Arm III
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Arm III
- description
- Given transdermally and orally
- name
- nicotine
- type
- DRUG
- arm Group Labels
- Arm I
- description
- Given orally
- name
- varenicline
- type
- DRUG
- arm Group Labels
- Arm II
- description
- Given orally
- name
- placebo
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- PREVENTION
Enrollment
- count
- 315
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of participants with self-reported, 7-day abstinence at 6-months
- measure
- Self- Reported 7-day Abstinence
- time Frame
- 6 Months
- description
- Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
- measure
- Carbon Monoxide (CO)-Confirmed 7-day Abstinence
- time Frame
- 6-Months
- description
- Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
- measure
- Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
- time Frame
- 6-Months
- description
- Number of participants with self-reported 7-day abstinence at 12-months
- measure
- Self-reported 7-day Abstinence
- time Frame
- 12 Months
- description
- Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
- measure
- CO-confirmed 7-day Abstinence
- time Frame
- 12 Months
- secondary Outcomes
- description
- Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
- measure
- Change in Smoking Urges
- time Frame
- 6 months
- description
- Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
- measure
- Withdrawal Symptoms
- time Frame
- 6 months
- measure
- Retention in Methadone Maintenance
- time Frame
- 12 months
- measure
- Methadone Dose Changes
- time Frame
- 12 months
- measure
- Use of Illicit Drugs as Measured by Urine Toxicologies
- time Frame
- 12 months
- description
- Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
- measure
- Reinforcing Effects of Smoking
- time Frame
- 6 months
- description
- Change in mean cigarettes per day
- measure
- Change in Cigarettes Per Day
- time Frame
- 6-Months
Full study description
- brief Summary
- 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.
- detailed Description
- OBJECTIVES: Primary * To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers. Secondary * To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking. * To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies. OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms. At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number. * Arm I (varenicline): 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. * Arm II (placebo): 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. * Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing). NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer. PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
Source references
- references
- citation
- Stein 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
- type
- BACKGROUND
- citation
- Livingstone-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
- type
- DERIVED
- citation
- de 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
- type
- DERIVED
- citation
- Caviness 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice