Nicotine DependencePhase 2BaclofenNCT01228994
Baclofen for Smoking Cessation in a Non-Psychiatric Population
A Phase 2 study testing Baclofen 30 mg/day and Baclofen 60 mg/day in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Baclofen 30 mg/day and Baclofen 60 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Aug 2012
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults (18 years or older).
- Meet DSM-IV criteria for nicotine dependence,
- Smoke ≥10 cigarettes/day,
- Baseline FTND score ≥4, CO level ≥10,
- have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
- No previous use of medication for smoking cessation in 1 month prior to randomization.
- BMI between 15 and 40 inclusive.
Who cannot join
- Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
- Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
- Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
- Are pregnant, are trying to become pregnant or are currently breastfeeding
- Baclofen hypersensitivity .
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Addiction and Mental Health- 33 Russell St
Toronto, Ontario, M5S2S1
About this study
Official title: Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.
The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group.
The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.
Read the detailed description
This study will test a new medication strategy designed to help smokers quit. It will evaluate Baclofen, a drug currently approved and available in Canada as a myorelaxant. Forty five nicotine-dependent smokers will enroll in this study. Fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. Once enrolled, subjects will visit CAMH on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, BP and AE screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. The medication phase of this study lasts 12 weeks. Two follow-up visits will be scheduled at week 13 and at six months after trial completion.
- Conditions
- Nicotine Dependence
- Being tested
- Baclofen 30 mg/day, placebo pill, Baclofen 60 mg/day
- Keywords
- smoking cessation treatment, baclofen, Smoking cessation counselling
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 30 mg/dayDrug
Also called Lioresal, Kemstro
Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease
placebo pillDrug
placebo pill
Baclofen 60 mg/dayDrug
Also called Lioresal, Kemstro
baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease
| Study group | Role | What they receive |
|---|---|---|
| Baclofen 30 mg/day | Active comparator | Baclofen medication Receives: Drug: Baclofen 30 mg/day |
| Placebo pill | Placebo comparator | placebo pill Receives: Drug: placebo pill |
| Baclofen 60 mg/day | Active comparator | Baclofen medication high dose Receives: Drug: Baclofen 60 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence for 7 days at end of treatment
At end of treatment subjects will report smoking consumption for past 7 days. Subject are considered abstinent based on self report and verfied by CO level (<10 PPM)
Measured: end of treatment week 10
Abstinent rate: last four weeks of trial
subjects report cigarette consumption during the last 4 weeks of the clinical trial.
abstinence rates are verifed by CO < 10 PPM
Measured: last 4 weeks of trial (week 7 to 10)
abstinence rate: for past 7 days at 6 month followup
Subject are asked to attend a 6 month followup. At this time subjects will be asked to report their cigarette consumption for the past 7 days.
abstinence is based on this self report and verified by CO levels <10 PPM
Measured: 6 month followup
Secondary outcomes (2)
Tiffany Questionnaire of Smoking Urges
tobacco craving is monitored at different time points of the trial
Measured: screen, week 1,4,7,10, abd 6 month followup
Minnesota Nicotine Withdrawal Scale
This scale assesses symptoms of tobacco withdrawal including nicotine craving, irritability, anziety, difficulty conentrating, restlessness, headaches, fatigue, increased appetite, weight gain, and insomnia.
Measured: Screen, week 1,4,7,10 and 6 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: The study was terminated because of difficulties recruiting subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228994
- Sponsor's protocol ID
- 1632009
- Acronym
- Baclofen
- Status last verified
- Sep 2013
- First submitted
- 25 Oct 2010
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
- ClinicalTrials.gov ID
- NCT01228994
- Acronym / sponsor ID
- Baclofen / 1632009
- Conditions
- Nicotine Dependence
- Keywords
- smoking cessation treatment, baclofen, Smoking cessation counselling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of difficulties recruiting subjects.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Oct 2010 (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 primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.
The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group.
The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.
Detailed description
This study will test a new medication strategy designed to help smokers quit. It will evaluate Baclofen, a drug currently approved and available in Canada as a myorelaxant. Forty five nicotine-dependent smokers will enroll in this study. Fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. Once enrolled, subjects will visit CAMH on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, BP and AE screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. The medication phase of this study lasts 12 weeks. Two follow-up visits will be scheduled at week 13 and at six months after trial completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baclofen 30 mg/day | Active comparator | Drug: Baclofen 30 mg/dayBaclofen medication |
| Placebo pill | Placebo comparator | Drug: placebo pillplacebo pill |
| Baclofen 60 mg/day | Active comparator | Drug: Baclofen 60 mg/dayBaclofen medication high dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female adults (18 years or older).
- Meet DSM-IV criteria for nicotine dependence,
- Smoke ≥10 cigarettes/day,
- Baseline FTND score ≥4, CO level ≥10,
- have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
Key exclusion criteria (6 listed)
- Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
- Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
- Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
- Are pregnant, are trying to become pregnant or are currently breastfeeding
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 |
|---|---|---|
| Baclofen 30 mg/dayAlso: Lioresal, KemstroBaclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease | Drug | Baclofen 30 mg/day |
| placebo pillplacebo pill | Drug | Placebo pill |
| Baclofen 60 mg/dayAlso: Lioresal, Kemstrobaclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease | Drug | Baclofen 60 mg/day |
Primary outcome
Smoking abstinence for 7 days at end of treatment
Time frame: end of treatment week 10
At end of treatment subjects will report smoking consumption for past 7 days. Subject are considered abstinent based on self report and verfied by CO level (<10 PPM)
Abstinent rate: last four weeks of trial
Time frame: last 4 weeks of trial (week 7 to 10)
subjects report cigarette consumption during the last 4 weeks of the clinical trial. abstinence rates are verifed by CO < 10 PPM
abstinence rate: for past 7 days at 6 month followup
Time frame: 6 month followup
Subject are asked to attend a 6 month followup. At this time subjects will be asked to report their cigarette consumption for the past 7 days. abstinence is based on this self report and verified by CO levels <10 PPM
2 secondary outcomes
Tiffany Questionnaire of Smoking Urges
Time frame: screen, week 1,4,7,10, abd 6 month followup
Minnesota Nicotine Withdrawal Scale
Time frame: Screen, week 1,4,7,10 and 6 month followup
Results and safety
The study was stopped early (reason given: The study was terminated because of difficulties recruiting subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
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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.
Bernard Le Foll, MD, PhD principal investigator
Centre for Addiction and Mental Health
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 Baclofen 30 mg/day and Baclofen 60 mg/day in people with Nicotine Dependence, run by Centre for Addiction and Mental 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Sep 2013. 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?
The study was stopped early (reason given: The study was terminated because of difficulties recruiting subjects.). 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?
Smoking abstinence for 7 days at end of treatment (time frame: end of treatment week 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2013.