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Baclofen Effects on Marijuana Dependence

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ClinicalTrials.gov Identifier: NCT02011516
Recruitment Status : Completed
First Posted : December 13, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Teresa Franklin, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 13, 2013
Results First Submitted Date  ICMJE November 23, 2016
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
Urine Drug Screen [ Time Frame: study weeks 1-12 ]
Change from positive to negative over the 12 weeks of a medication regimen
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
Change in brain and behavioral responses during reward and inhibitory tasks at fMRI 1, fMRI 2, and fMRI 3; A composite measure [ Time Frame: Before medication @ baseline (fMRI 1), during medication @ week 3 (fMRI 2) and after medication @ week 13 (fMRI 3) ]
Change History Complete list of historical versions of study NCT02011516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen Effects on Marijuana Dependence
Official Title  ICMJE A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Dependence
Intervention  ICMJE
  • Drug: Baclofen
    Other Names:
    • Kemstro
    • Lioresal
    • Liofen
    • Gablofen
    • Beklo
  • Behavioral: Psychosocial
  • Drug: Placebo
    Other Name: Sugar pill
Study Arms  ICMJE
  • Placebo Comparator: Sugar pill, psychosocial intervention
    twice weekly appointments with a certified clinician
    Interventions:
    • Behavioral: Psychosocial
    • Drug: Placebo
  • Active Comparator: Baclofen, psychosocial intervention
    20 mg. q.i.d. twice weekly appointments with a certified clinician
    Interventions:
    • Drug: Baclofen
    • Behavioral: Psychosocial
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2017)
47
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2013)
77
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02011516
Other Study ID Numbers  ICMJE 818755
CURE CANN ( Other Identifier: Center for the Studies of Addiction )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teresa Franklin, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Pennsylvania Department of Health
Investigators  ICMJE
Principal Investigator: Teresa R Franklin, Ph.D. University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP