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Baclofen for Smoking Cessation in a Non-Psychiatric Population (Baclofen)

Primary Purpose

Nicotine Dependence

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Baclofen 30 mg/day

placebo pill

Baclofen 60 mg/day

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring smoking cessation treatment, baclofen, Smoking cessation counselling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

Centre for Addiction and Mental Health- 33 Russell St

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Baclofen 30 mg/day

Placebo pill

Baclofen 60 mg/day

Arm Description

Baclofen medication

placebo pill

Baclofen medication high dose

Outcomes

Primary Outcome Measures

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)

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

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

Secondary Outcome Measures

Tiffany Questionnaire of Smoking Urges

tobacco craving is monitored at different time points of the trial

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.

Full Information

NCT ID

NCT01228994

First Posted

October 25, 2010

Last Updated

September 11, 2013

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Tobacco Control Research Initiative

1. Study Identification

Unique Protocol Identification Number

NCT01228994

Brief Title

Baclofen for Smoking Cessation in a Non-Psychiatric Population

Acronym

Baclofen

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated because of difficulties recruiting subjects.

Study Start Date

October 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Tobacco Control Research Initiative

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

smoking cessation treatment, baclofen, Smoking cessation counselling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baclofen 30 mg/day

Arm Type

Active Comparator

Arm Description

Baclofen medication

Arm Title

Placebo pill

Arm Type

Placebo Comparator

Arm Description

placebo pill

Arm Title

Baclofen 60 mg/day

Arm Type

Active Comparator

Arm Description

Baclofen medication high dose

Intervention Type

Drug

Intervention Name(s)

Baclofen 30 mg/day

Other Intervention Name(s)

Lioresal, Kemstro

Intervention Description

Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease

Intervention Type

Drug

Intervention Name(s)

placebo pill

Intervention Description

placebo pill

Intervention Type

Drug

Intervention Name(s)

Baclofen 60 mg/day

Other Intervention Name(s)

Lioresal, Kemstro

Intervention Description

baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease

Primary Outcome Measure Information:

Title

Smoking abstinence for 7 days at end of treatment

Description

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)

Time Frame

end of treatment week 10

Title

Abstinent rate: last four weeks of trial

Description

subjects report cigarette consumption during the last 4 weeks of the clinical trial. abstinence rates are verifed by CO < 10 PPM

Time Frame

last 4 weeks of trial (week 7 to 10)

Title

abstinence rate: for past 7 days at 6 month followup

Description

Time Frame

6 month followup

Secondary Outcome Measure Information:

Title

Tiffany Questionnaire of Smoking Urges

Description

tobacco craving is monitored at different time points of the trial

Time Frame

screen, week 1,4,7,10, abd 6 month followup

Title

Minnesota Nicotine Withdrawal Scale

Description

Time Frame

Screen, week 1,4,7,10 and 6 month followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernard Le Foll, MD, PhD

Organizational Affiliation

Centre for Addiction and Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Addiction and Mental Health- 33 Russell St

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S2S1

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.camh.net/research

Description

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

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Baclofen for Smoking Cessation in a Non-Psychiatric Population

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