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
Smoking Tobacco - Use Disorder Nicotine Dependence Nicotine - Use Disorder	Drug: Baclofen

Further study details as provided by Department of Veterans Affairs:

Primary Outcomes: Effects on smoking urge, withdrawal, and reinforcement (determined behaviorally during a behavioral economics procedure) after 4 -7 hours of smoking deprivation on Day 10 of medication
Secondary Outcomes: Nicotine self-administration, as quantified by salivary cotinine on Day 10 of medication, after 4 – 5 hours of smoking deprivation and an opportunity to smoke during a behavioral economics procedure
Expected Total Enrollment:  150

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 132 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Smoke at least 10 cigarettes per day for at least 2 years

Exclusion Criteria:

• Weight less than 120 lbs. or above 240 lbs.Use of tobacco products other than cigarettes in the previous monthHistory of:

  • Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary disease, diabetes, hypertension)
  • Neurological disease (including stroke, mini-stroke, brain injury, Alzheimer’s Disease, encephalitis, meningitis, seizure disorder)
  • Phenylketonuria
  • Schizophrenia, Schizoaffective Disorder, Paranoid Disorder, or Schizotypal Disorder Current alcohol and/or drug use disorder For women: Pregnancy, nursing, not using a reliable form of birth controlAllergy to baclofen, Lioresal, Kemstro, or acetaminophen (Tylenol)Taking the following medications: antidepressants (excluding SSRIs), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockersLive with someone enrolled in the study Planning to attempt smoking cessation within the next 3 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00257894

Sara Dolan, PhD      401-444-1843    sara_dolan@brown.edu
Damaris J Rohsenow, PhD      401-444-1843    damaris_rohsenow@brown.edu

Rhode Island
      Providence Veterans Affairs Medical Center, Providence,  Rhode Island,  02908,  United States

Study chairs or principal investigators

Damaris J Rohsenow, PhD,  Principal Investigator,  Providence Veterans Affairs Medical Center   

Study ID Numbers:  NEUA-029-04F; DR-0024
Last Updated:  December 8, 2005
Record first received:  November 21, 2005
ClinicalTrials.gov Identifier:  NCT00257894
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10