Baclofen Effects on Marijuana Dependence
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/21/2016 |
Start Date: | December 2013 |
End Date: | June 2015 |
A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence
Studies show that certain reminders of drug use such as the sight of someone using
marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users
to smoke marijuana. We are measuring the brain and behavioral responses of marijuana
dependent individuals to these reminders (cues) We will examine brain responses during cue
exposure and determine whether these responses are associated with treatment outcome.
We are testing the hypothesis that the medication baclofen reduces brain responses during
marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is
FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional
magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana
cues. fMRI is a painless technique that takes special pictures of the brain (or other parts
of your body). It does not involve radiation or injections.
Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%
chance of receiving baclofen. Neither the participant nor study personnel will know whether
participants are receiving baclofen or placebo. Participants will also receive twice weekly
psychosocial treatment with a certified clinician. Twelve weeks of treatment will be
followed by a 12 week follow up.
marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users
to smoke marijuana. We are measuring the brain and behavioral responses of marijuana
dependent individuals to these reminders (cues) We will examine brain responses during cue
exposure and determine whether these responses are associated with treatment outcome.
We are testing the hypothesis that the medication baclofen reduces brain responses during
marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is
FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional
magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana
cues. fMRI is a painless technique that takes special pictures of the brain (or other parts
of your body). It does not involve radiation or injections.
Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%
chance of receiving baclofen. Neither the participant nor study personnel will know whether
participants are receiving baclofen or placebo. Participants will also receive twice weekly
psychosocial treatment with a certified clinician. Twelve weeks of treatment will be
followed by a 12 week follow up.
Inclusion Criteria:
- Physically healthy, as determined by a comprehensive physical examination and
approval of the study physician, and mentally stable, as determined by a
psychological evaluation by a licensed clinician, males or females who meet
Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for
marijuana dependence, ages 18-60.
- 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.]
- 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.
- Intelligence quotient of ≥ 80.
- Provide voluntary informed consent.
Exclusion Criteria:
- Participation in a clinical trial and receipt of investigational drug(s) during the
previous 60 days.
- 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.
- Current use of non-removable medicated or nicotine skin patches.
- Current or prior gambling problems (assessed by subject's self-report).
- Current treatment for marijuana dependence.
- Any other current drug dependence diagnoses (except nicotine dependence).
- Any other psychiatric diagnoses. Current diagnosis/recent history (within past 6
months) of Major Depressive Disorder (MDD).
- History of head trauma or injury causing loss of consciousness, lasting more than
three (3) minutes or associated with skull fracture or inter-cranial bleeding or
abnormal Magnetic Resonance Imaging (MRI).
- Claustrophobia or other medical condition preventing subject from lying in the MRI
for approximately one (1) hour.
- Clinically significant cardiovascular, hematologic, hepatic (liver), renal (kidney),
neurological, or endocrinological abnormalities, bloodwork, and/or electrocardiogram
(EKG).
- Uncontrolled diabetes or uncontrolled hypertension.
- History of psychosis, seizures, or organic brain syndrome.
- Vision problems that cannot be corrected with glasses.
- Weight exceeding 300 pounds [Imaging data acquisition is impaired with high weight
individuals].
- History of stroke.
Case-by-Case:
- Human immunodeficiency virus (HIV) positive on medication for symptoms. This will be
determined on an individual basis by results from the physical examination and final
approval by our study physician; all results from the physical within normal range
for study inclusion.
- Use of medications or natural herbs that cause sedation or affect the brain systems
that are being studied. Medication use will be evaluated by our study physician on a
case-by-case basis. For example, if the subject takes Benadryl but can safely refrain
from use 24 hours prior to scanning sessions, they will not be excluded.
- Significant history of past alcohol or substance abuse.
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