Baclofen for Smoking Cessation in a Non-Psychiatric Population

Nicotine Dependence Clinical Trial

— Baclofen  

Official title:

Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01228994
• Other study ID #: 1632009
• Status: Terminated
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: September 11, 2013
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Baclofen 30 mg/day
Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease
• placebo pill
placebo pill
• Baclofen 60 mg/day
baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health- 33 Russell St	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Tobacco Control Research Initiative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	end of treatment week 10	No
Primary	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	last 4 weeks of trial (week 7 to 10)	No
Primary	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	6 month followup	No
Secondary	Tiffany Questionnaire of Smoking Urges	tobacco craving is monitored at different time points of the trial	screen, week 1,4,7,10, abd 6 month followup	No
Secondary	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.	Screen, week 1,4,7,10 and 6 month followup	No

External Links

•   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 Centre