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Baclofen Effects on Marijuana Dependence

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baclofen
Psychosocial
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring Marijuana, Addiction, fMRI, Baclofen, Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pennsylvania Center for Studies of Addiction

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar pill, psychosocial intervention

Baclofen, psychosocial intervention

Arm Description

twice weekly appointments with a certified clinician

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2013
Last Updated
June 12, 2017
Sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT02011516
Brief Title
Baclofen Effects on Marijuana Dependence
Official Title
A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
Marijuana, Addiction, fMRI, Baclofen, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill, psychosocial intervention
Arm Type
Placebo Comparator
Arm Description
twice weekly appointments with a certified clinician
Arm Title
Baclofen, psychosocial intervention
Arm Type
Active Comparator
Arm Description
20 mg. q.i.d. twice weekly appointments with a certified clinician
Intervention Type
Drug
Intervention Name(s)
Baclofen
Other Intervention Name(s)
Kemstro, Lioresal, Liofen, Gablofen, Beklo
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
Urine Drug Screen
Description
Change from positive to negative over the 12 weeks of a medication regimen
Time Frame
study weeks 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa R Franklin, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Center for Studies of Addiction
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Baclofen Effects on Marijuana Dependence

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