Status:
TERMINATED
Baclofen Effects on Smoking Urge and Withdrawal
Lead Sponsor:
VA Office of Research and Development
Conditions:
Nicotine Use Disorder
Nicotine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-
Exclusion
- 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 selective serotonin reuptake inhibitors), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockers.
- Lives with someone enrolled in the study.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00257894
Start Date
December 1 2005
End Date
December 1 2008
Last Update
November 4 2015
Active Locations (1)
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1
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908