Status:
COMPLETED
Neural Substrates in Nicotine Withdrawal
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar) will help reduce cognitive problems that smokers experience when they quit. This study will also determine w...
Detailed Description
Tolcapone, an FDA-approved treatment for Parkinson's disease, improves cognitive performance in healthy controls with COMT val/val genotypes, putatively by increasing prefrontal dopamine levels. We pr...
Eligibility Criteria
Inclusion
- Smokers who are between 18 and 65 years of age who self-report smoking at least 10 cigarettes (menthol and non-menthol) per day for at least the last 6 months.
- Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, psychiatric evaluation, and liver function tests (LFTs and GGT enzyme levels).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Women of childbearing potential must consent to use a medically accepted method of birth control while participating in the study (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation) and have 3 months of regular menstrual cycles.
- Capable of providing a Carbon Monoxide (CO) breath test reading greater than 10 parts per million (ppm) at the medical screening visit.
Exclusion
- Smoking behavior
- Current enrollment or plans to enroll in another research or smoking cessation program in the next 3 months.
- Provide a CO reading less than or equal to 10ppm at the medical screening visit.
- Plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) while enrolled in the study.
- Alcohol/Drug Exclusion:
- History (past 2 years) or current diagnosis of substance abuse and/or currently receiving treatment for substance abuse (alcohol, THC, cocaine, PCP, amphetamines, methamphetamines, MDMA/ecstasy, opiates, methadone, benzodiazepines, tricyclic antidepressants, and barbiturates).
- Current alcohol consumption that exceeds 21 standard drinks/week over the last 6 months.
- Positive urine drug screen (for substances listed previously) at the medical screening visit or either testing day.
- Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at medical screening visit or either testing day.
- Medication
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01001520
Start Date
January 1 2010
End Date
October 1 2012
Last Update
July 2 2014
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104