Baclofen for Smoking Cessation in a Non-Psychiatric Population

NCT01228994 | Terminated Phase 2

• 1 other identifier: 1632009
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

smoking cessation treatment; baclofen; Smoking cessation counselling

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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

Secondary Outcomes (2)

• Tiffany Questionnaire of Smoking Urges

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

• Minnesota Nicotine Withdrawal Scale

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

Study Arms (3)

Baclofen 30 mg/day

ACTIVE COMPARATOR

Baclofen medication

Drug: Baclofen 30 mg/day

Placebo pill

PLACEBO COMPARATOR

placebo pill

Drug: placebo pill

Baclofen 60 mg/day

ACTIVE COMPARATOR

Baclofen medication high dose

Drug: Baclofen 60 mg/day

Interventions

Baclofen 30 mg/day DRUG

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

Also known as: Lioresal, Kemstro

Baclofen 30 mg/day

placebo pill DRUG

placebo pill

Placebo pill

Baclofen 60 mg/day DRUG

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

Also known as: Lioresal, Kemstro

Baclofen 60 mg/day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Tobacco Control Research Initiative: collaborator

Study Sites (1)

Centre for Addiction and Mental Health- 33 Russell St

Toronto, Ontario, M5S2S1, Canada

Location

Related 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

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Bernard Le Foll, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

CA (1)