Baclofen Effects on Marijuana Dependence

NCT02011516 | Completed Phase 2 Results

• 2 other identifiers: 818755CURE CANN
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marijuana Dependence

Keywords

Marijuana; Addiction; fMRI; Baclofen; Treatment

Outcome Measures

Primary Outcomes (1)

• Urine Drug Screen

  Change from positive to negative over the 12 weeks of a medication regimen

  study weeks 1-12

Study Arms (2)

Sugar pill, psychosocial intervention

PLACEBO COMPARATOR

twice weekly appointments with a certified clinician

Behavioral: Psychosocial; Drug: Placebo

Baclofen, psychosocial intervention

ACTIVE COMPARATOR

20 mg. q.i.d. twice weekly appointments with a certified clinician

Drug: Baclofen; Behavioral: Psychosocial

Interventions

Baclofen DRUG

Also known as: Kemstro, Lioresal, Liofen, Gablofen, Beklo

Baclofen, psychosocial intervention

Psychosocial BEHAVIORAL

Baclofen, psychosocial intervention; Sugar pill, psychosocial intervention

Placebo DRUG

Also known as: Sugar pill

Sugar pill, psychosocial intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Behavior, Addictive

Interventions

Baclofen; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Carbohydrates

Limitations and Caveats

Sample size too sample to draw conclusions. No subject was able to provide a negative cannabis urine throughout treatment. A caveat is that cannabis stays in the urine for 6 weeks after final use.

Results Point of Contact

• Title: Teresa R. Franklin, Ph.D., Research Associate Professor of Neuroscience in Psychiatry
• Organization: University of Pennsylvania

teresafr@mail.med.upenn.edu

215-222-3200

Study Officials

• Teresa R Franklin, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Neuroscience in Psychiatry

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-06

Locations

US (1)