Status:
COMPLETED
Baclofen Effects in Cigarette Smokers
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the ...
Eligibility Criteria
Inclusion
- Physically healthy, as determined by a comprehensive physical examination and approval of the study physician males or females who smoke cigarettes, ages 18-60.
- Smoke ≥ 6 cigarettes per day for at least 6 months prior to study start date.
- Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), the Nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection or complete abstinence.
- Provide voluntary informed consent.
- Must be able to read. \[Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.\]
- Intelligence quotient of ≥ 80.
Exclusion
- History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- Current Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnoses other than nicotine dependence.
- Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
- History of psychosis.
- Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.
- Current diagnosis of or treatment within the last 3 months for alcohol dependence.
- Current use of any smoking cessation treatments such as Zyban, Chantix, Wellbutrin, patch, gum, inhaler, electronic cigarettes, herbal preparations.
- Vision problems that cannot be corrected with glasses.
- Weight exceeding 300 pounds \[Imaging data acquisition is impaired with high weight individuals\].
- History of stroke.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01821560
Start Date
March 1 2013
End Date
June 1 2017
Last Update
December 19 2018
Active Locations (1)
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1
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104