SmokingPhase 2MMTASCNCT00906386
Methadone Maintenance Treatment and Smoking Cessation
A Phase 2 study testing Varenicline in people with Smoking, run by Vancouver Coastal Health at 1 site in Canada.
Trial summary
The main hypotheses guiding the study are: 1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Smoking
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Three Bridges Community Health Centre
Vancouver, British Columbia, V6Z 1W2
About this study
Official title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
The main hypotheses guiding the study are:
- Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
- There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
- There will be no changes in methadone dosage between abstinent and non-abstinent smokers
- There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
Read the detailed description
- PURPOSE: The purpose of this placebo controlled study is to determine the efficacy, safety, and gender differences in using varenicline for smoking cessation in a population of stable methadone maintenance patients being treated for Opioid Dependence.
- HYPOTHESIS:
1.Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2.There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo 3.There will be no changes in methadone dosage between abstinent and non-abstinent smokers 4.There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
- JUSTIFICATION: Patients on methadone maintenance treatment have smoking prevalence rates of up 80-90% and consequently disproportionately high mortality compared to the general population. A majority of these patients express a desire to quit but are generally more heavily dependent on nicotine. Randomized controlled trials in non-drug using populations have shown varenicline to be more efficacious for smoking cessation than placebo and other smoking cessation medications. This placebo controlled research protocol will examine varenicline's effect on smoking cessation/reduction and potential sex and gender differences in a population of methadone maintained patients.
- OBJECTIVES:
Primary outcome:
- Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12).
Secondary outcomes:
- 7-day point prevalence of abstinence
- Continuous abstinence Weeks 9-26
- Sex and gender differences
- Psychological assessment (Beck Depression Inventory)
- Adverse effects (Nausea, Dry mouth, Flatulence, Constipation, Insomnia, -Abnormal dreams, Irritability, Sleep disorder, Headaches, Dizziness e.t.c.)
- RESEARCH METHOD: This pilot randomized, double-blind, placebo-controlled trial will be conducted at Vancouver Coastal Health Tobacco Dependence Clinic Vancouver, BC with a 12-week treatment period and follow-up of smoking status to week 26. The intervention will include the use of Varenicline titrated to 1 mg twice daily or placebo for 12 weeks, plus weekly brief smoking cessation counseling.
- All significance tests will be 2-tailed with an overall level of significance of a = 0.05. The primary outcome will be the analysis of continuous abstinence using a logistic regression model. The secondary outcomes will be:
- the analysis of 7-day abstinence and 9-26 week continuous abstinence using logistic regression analysis.
- Minnesota Nicotine Withdrawal Scale, Beck's Depression Inventory, and changes in methadone dose outcome using repeated measures analysis, and
- Chi-square tests and t-tests (or Mann-Whitney U) to determine sex and gender differences (male vs female) as well as differences in adverse effects of treatment (varenicline vs placebo)
- Conditions
- Smoking
- Being tested
- Varenicline, placebo
- Keywords
- Varenicline
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix, Chantix
oral, 1 mg twice daily, 12 weeks
placeboDrug
oral, 1 mg twice daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Varenicline |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence
Measured: 9-12 weeks; 9-26
Secondary outcomes (1)
Sex differences in the efficacy, withdrawal symptoms, and safety of varenicline
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health
- Sponsor type
- Other government
- Collaborators
- British Columbia Centre of Excellence for Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906386
- Sponsor's protocol ID
- 60409
- Acronym
- MMTASC
- Status last verified
- May 2009
- First submitted
- 15 May 2009
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
- ClinicalTrials.gov ID
- NCT00906386
- Acronym / sponsor ID
- MMTASC / 60409
- Conditions
- Smoking
- Keywords
- Varenicline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Vancouver Coastal HealthOther government
- Collaborators
- British Columbia Centre of Excellence for Women's Health
- Study start
- May 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main hypotheses guiding the study are:
- Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
- There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
- There will be no changes in methadone dosage between abstinent and non-abstinent smokers
- There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
Detailed description
- PURPOSE: The purpose of this placebo controlled study is to determine the efficacy, safety, and gender differences in using varenicline for smoking cessation in a population of stable methadone maintenance patients being treated for Opioid Dependence.
- HYPOTHESIS:
1.Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2.There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo 3.There will be no changes in methadone dosage between abstinent and non-abstinent smokers 4.There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants
- JUSTIFICATION: Patients on methadone maintenance treatment have smoking prevalence rates of up 80-90% and consequently disproportionately high mortality compared to the general population. A majority of these patients express a desire to quit but are generally more heavily dependent on nicotine. Randomized controlled trials in non-drug using populations have shown varenicline to be more efficacious for smoking cessation than placebo and other smoking cessation medications. This placebo controlled research protocol will examine varenicline's effect on smoking cessation/reduction and potential sex and gender differences in a population of methadone maintained patients.
- OBJECTIVES:
Primary outcome:
- Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12).
Secondary outcomes:
- 7-day point prevalence of abstinence
- Continuous abstinence Weeks 9-26
- Sex and gender differences
- Psychological assessment (Beck Depression Inventory)
- Adverse effects (Nausea, Dry mouth, Flatulence, Constipation, Insomnia, -Abnormal dreams, Irritability, Sleep disorder, Headaches, Dizziness e.t.c.)
- RESEARCH METHOD: This pilot randomized, double-blind, placebo-controlled trial will be conducted at Vancouver Coastal Health Tobacco Dependence Clinic Vancouver, BC with a 12-week treatment period and follow-up of smoking status to week 26. The intervention will include the use of Varenicline titrated to 1 mg twice daily or placebo for 12 weeks, plus weekly brief smoking cessation counseling.
- All significance tests will be 2-tailed with an overall level of significance of a = 0.05. The primary outcome will be the analysis of continuous abstinence using a logistic regression model. The secondary outcomes will be:
- the analysis of 7-day abstinence and 9-26 week continuous abstinence using logistic regression analysis.
- Minnesota Nicotine Withdrawal Scale, Beck's Depression Inventory, and changes in methadone dose outcome using repeated measures analysis, and
- Chi-square tests and t-tests (or Mann-Whitney U) to determine sex and gender differences (male vs female) as well as differences in adverse effects of treatment (varenicline vs placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Varenicline |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: Champix, Chantixoral, 1 mg twice daily, 12 weeks | Drug | 1 |
| placebooral, 1 mg twice daily, 12 weeks | Drug | placebo |
Primary outcome
7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence
Time frame: 9-12 weeks; 9-26
1 secondary outcome
Sex differences in the efficacy, withdrawal symptoms, and safety of varenicline
Time frame: week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 37142273Livingstone-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline in people with Smoking, run by Vancouver Coastal Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (time frame: 9-12 weeks; 9-26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.