Baclofen Effects on Smoking Urge and Withdrawal

This study has been terminated.
(Enrollment was completed with insufficient sample size for publishable results)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00257894
First received: November 21, 2005
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.


Condition Intervention
Nicotine Use Disorder
Nicotine Dependence
Smoking
Tobacco Use Disorder
Drug: Baclofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Baclofen Effects on Smoking Urge and Withdrawal

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Two measures are equally important: 1) Total score on Questionnaire of Smoking Urges; 2) Minnesota Nicotine Withdrawal Scale [ Time Frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. ] [ Designated as safety issue: No ]
    Questionnaire of Smoking Urges assesses cravings to smoke. Minesota Nicotine Withdrawal Questionnaire assesses nicotine withdrawal


Secondary Outcome Measures:
  • Nicotine self-administration as quantified by salivary cotinine boost during a behavioral self-administration task. [ Time Frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. ] [ Designated as safety issue: No ]
  • Cigarette choice task [ Time Frame: Tenth day of medication titration ] [ Designated as safety issue: No ]
    Number of choices for cigarette puffs vs. financial incentive in a behavioral economics procedure.


Estimated Enrollment: 64
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Healthy people from the surrounding community who smoke at least 10 cigarettes per day and not ready to quit smoking
Drug: Baclofen
Dosing taken orally for a total of 12 days: 40mg/day vs. 20mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). The 20mg/day condition will receive 15mg/day the first 3 days(Days 1,2,3) and 20mg/day for the next 6 days(Days4-9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12). 20mg/day condition will receive 20mg/day(Day10), 10mg/day(Day11), and 5mg/day(Day12).

Detailed Description:

OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. The specific objectives of the present application are to investigate the dose-response effects of baclofen (a GABA-B agonist), 1) on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours of smoking deprivation.

RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4 hours of deprivation.

METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and who are motivated for future smoking cessation. On Day 0, a baseline session will occur after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be repeated after the final medication dose has been stabilized for at least 3 days and after 4 hours of supervised smoking deprivation has occurred. Medication differences in urge and withdrawal and in the reinforcement value of smoking cigarettes will be investigated. Dependent measures of urge and withdrawal will be by self-report. The dependent measure of reinforcement value is the ratio of choices for cigarette puffs versus money during a subsequent 2-1/2 hr period. The choice procedure will clarify the relative reinforcement value of smoking while controlling for non-specific decreases in general activity level resulting from sedation. Nicotine self-administration during the medication period will be quantified using saliva cotinine, as a secondary effect.

CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less suffering and mortality and in considerable savings in health care costs associated with cardiovascular disease, pulmonary disorders, and cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-

Exclusion Criteria:

  • Planning to attempt smoking cessation within the next 4 months
  • Weight less than 110 lbs. or above 220 lbs.
  • Use of tobacco products other than cigarettes in the previous month.
  • History of: Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke, brain injury, Alzheimers Disease, encephalitis, meningitis, seizure disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder, or Schizotypal Disorder.
  • Current alcohol and/or drug use disorder as indicated by a screening questionnaire, past treatment for alcohol or substance use problems unless in remission(clean and sober for past year or more) or intention to seek treatment in the next 6 months for alcohol or substance use problems.
  • For women: Pregnancy, nursing, not using a reliable form of birth control.
  • Allergy to baclofen, Lioresal, or Kemstro.
  • Taking the following medications: antidepressants(excluding SSRIs), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockers.
  • Lives with someone enrolled in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257894

Locations
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Investigators
Principal Investigator: Damaris Rohsenow, PhD VA Medical Center, Providence
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00257894     History of Changes
Other Study ID Numbers: NEUA-029-04F
Study First Received: November 21, 2005
Last Updated: November 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Baclofen
Conditioning, Classical
Nicotine
Smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014