Baclofen Effects on Marijuana Dependence

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02011516
• Collaborator: Pennsylvania Department of Health (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Dependence	Drug: Baclofen; Behavioral: Psychosocial; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Placebo-controlled Study of Baclofen on Brain and Behavioral Outcomes in Marijuana Dependence
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Urine Drug Screen [study weeks 1-12]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Center for Studies of Addiction	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Pennsylvania Department of Health

Investigators

• Principal Investigator: Teresa R Franklin, Ph.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teresa Franklin, Research Assistant Professor of Neuroscience in Psychiatry, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02011516
• Other Study ID Numbers: 818755; CURE CANN
• First Posted: Dec 13, 2013
• Last Update Posted: Jun 14, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Teresa Franklin, Research Assistant Professor of Neuroscience in Psychiatry, University of Pennsylvania: Marijuana; Addiction; fMRI; Baclofen; Treatment
• Additional relevant MeSH terms: Marijuana Abuse; Baclofen

Study Results

Participant Flow

Recruitment Details	Recruitment Timeframe: 12/2013-10/2014 Potential subjects were recruited via word of mouth, flyers, craigslist and targeted Facebook ads 47 potential subjects were enrolled (consented), 41 were screened, 22 passed screening, 21 baseline scan, 16 randomized, 13 treatment scan, 8 post-tx scan, 10 completed.
Pre-assignment Detail	All enrolled participants, those that consented to study procedures, participated in a screening process that consisted of a physical and psychological evaluation. Those participants that did not meet our specific inclusion criteria, and/or those that met our exclusion criteria, were not assigned to groups. These individuals were given referrals.

Arm/Group Title	Sugar Pill, Psychosocial Intervention	Baclofen, Psychosocial Intervention
Arm/Group Description	twice weekly appointments with a certified clinician Psychosocial Placebo	20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial
Period Title: Overall Study
STARTED	8	8
COMPLETED	4	6
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Sugar Pill, Psychosocial Intervention	Baclofen, Psychosocial Intervention	Total
Arm/Group Description	twice weekly appointments with a certified clinician Psychosocial Placebo	20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial	Total of all reporting groups
Overall Participants	8	8	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	8 100%	16 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 50%	3 37.5%	7 43.8%
Male	4 50%	5 62.5%	9 56.3%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	16 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill, Psychosocial Intervention	Baclofen, Psychosocial Intervention
Arm/Group Description	twice weekly appointments with a certified clinician Psychosocial Placebo	20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial
Measure Participants	8	8
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	study weeks 1-12
Arm/Group Title	Sugar Pill, Psychosocial Intervention		Baclofen, Psychosocial Intervention
Arm/Group Description	twice weekly appointments with a certified clinician Psychosocial Placebo		20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial
All Cause Mortality
	Sugar Pill, Psychosocial Intervention		Baclofen, Psychosocial Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Sugar Pill, Psychosocial Intervention		Baclofen, Psychosocial Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Sugar Pill, Psychosocial Intervention		Baclofen, Psychosocial Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/8 (50%)		4/8 (50%)
Gastrointestinal disorders
Constipation	1/8 (12.5%)		0/8 (0%)
Diarrhea	1/8 (12.5%)		0/8 (0%)
Flatulence	1/8 (12.5%)		0/8 (0%)
Nausea	1/8 (12.5%)		0/8 (0%)
Metallic Taste	1/8 (12.5%)		0/8 (0%)
Abdominal Cramping	0/8 (0%)		1/8 (12.5%)
Increase in Bowel Movements	0/8 (0%)		1/8 (12.5%)
General disorders
Headache	3/8 (37.5%)		0/8 (0%)
Dry Mouth	1/8 (12.5%)		0/8 (0%)
Metabolism and nutrition disorders
Unintended Weight Loss	0/8 (0%)		1/8 (12.5%)
Nervous system disorders
Drowsy/Sluggish	3/8 (37.5%)		1/8 (12.5%)
Slowed Cognition	1/8 (12.5%)		0/8 (0%)
"High" Feeling	1/8 (12.5%)		0/8 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.