Methadone Maintenance Treatment and Smoking Cessation

NCT00906386 | Unknown Phase 2

• 1 other identifier: 60409
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The main hypotheses guiding the study are:

1. 1.Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. 2.There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. 3.There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. 4.There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants

Conditions

Smoking

Keywords

Varenicline

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence

  9-12 weeks; 9-26

Secondary Outcomes (1)

• Sex differences in the efficacy, withdrawal symptoms, and safety of varenicline

  week 26

Study Arms (2)

1

EXPERIMENTAL

Drug: Varenicline

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Varenicline DRUG

oral, 1 mg twice daily, 12 weeks

Also known as: Champix, Chantix

1

placebo DRUG

oral, 1 mg twice daily, 12 weeks

placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable on methadone maintenance (an individual is considered 'stable' if they have had a 4 week constant/fixed dose of methadone by self report and verified by B.C. Pharmanet review)
• Subjects must have smoked at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year
• Ages 19 to 75 years (inclusive) and motivated to quit smoking
• Should read and understand English
• For female subjects:
• instructed and agrees to avoid pregnancy through 30 days after the last dose of study medication
• has a negative urine pregnancy test at screening
• agrees to use birth control method(s) for duration of the study
• Should be available by telephone

You may not qualify if:

• Subjects who have used varenicline previously or are currently on other Nicotine Replacement Therapy or pharmacotherapy for smoking cessation (e.g., nicotine patch, zyban or wellbutrin)
• Subjects who have a prior or current history of depression, bipolar affective disorder or a prior or current history of psychotic episodes or suicidal ideation (on the basis of self-report augmented by medical chart review where appropriate and/or corroborating history with previous or current health care provider)
• Subjects who have not reached a stable dose of methadone in their methadone maintenance therapy (4 weeks at a constant/fixed dose of methadone by self-report and verified by B.C. Pharmanet review)
• Pregnancy or currently nursing

Sponsors & Collaborators

• Vancouver Coastal Health: lead
• British Columbia Centre of Excellence for Women's Health: collaborator

Study Sites (1)

Three Bridges Community Health Centre

Vancouver, British Columbia, V6Z 1W2, Canada

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2011
• Last Updated: March 2, 2010

Record last verified: 2009-05

Locations

CA (1)