Smoking Clinical Trial
Official title:
Baclofen Effects on Smoking Urge and Withdrawal
Verified date | October 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 41 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 selective serotonin reuptake inhibitors), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockers. - Lives with someone enrolled in the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Providence | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Score on Questionnaire of Smoking Urges | Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10. |
Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. | No |
Primary | Minnesota Nicotine Withdrawal Questionnaire | Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal). These data are only available on the subset of participants who participated through Day 10. |
Day 10 | No |
Secondary | Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task. | Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse). These data are only available on the subset of participants who participated through Day 10.. |
Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation. | No |
Secondary | Cigarette Choice Task | At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed). These data are only available on the subset of participants who participated through Day 10. |
Tenth day of medication titration | No |
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