Baclofen Effects on Marijuana Dependence

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Dependence
• Intervention / Treatment: Drug: Placebo; Drug: Baclofen; Behavioral: Psychosocial

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Center for Studies of Addiction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar pill, psychosocial intervention; twice weekly appointments with a certified clinician	Drug: Placebo; Other Names: Sugar pill; Behavioral: Psychosocial
Active Comparator: Baclofen, psychosocial intervention; 20 mg. q.i.d. twice weekly appointments with a certified clinician	Drug: Baclofen; Other Names: Lioresal; Gablofen; Kemstro; Liofen; Beklo; Behavioral: Psychosocial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Drug Screen	Change from positive to negative over the 12 weeks of a medication regimen	study weeks 1-12

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Teresa R Franklin, Ph.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; fMRI; Addiction; Marijuana; Baclofen
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: 818755; CURE CANN (Other Identifier: Center for the Studies of Addiction)