A Study of Baclofen ER

Study Overview
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Brief Summary
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This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.

Official Title
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A Randomized Placebo-controlled Study of Baclofen ER on Brain and Behavioral Outcomes in Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Baclofen ER
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence. 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), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence. Reading level at or above eighth grade. Participants provide voluntary informed consent. Smoking is primary route of cocaine administration. Available for an inpatient stay. Exclusion Criteria: Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility. Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes. Current or prior gambling problems (assessed by participants self-report) Non-removable skin patches Have received medication that could interact adversely with baclofen, including muscle relaxants (including tricyclic antidepressants), antiseizure medication, CNS depressants (tranquilizers, sleeping pills), MAO inhibitors), within the time of administration of study agent based on the study physician's guidance (e.g. 5 half lives) Have known or suspected hypersensitivity to baclofen. Be taking baclofen for any reason currently or during the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baclofen ER versus Placebo<br>Baclofen ER versus Placebo (sugar pill) | Drug: Baclofen ER<br>* Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication<br>|
| Placebo Comparator: Placebo versus Baclofen ER<br>Participants will receive either placebo (sugar pill) or Baclofen ER | Drug: Placebo<br>* Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urines positive for benzoylecgonine (BE), (a metabolite of cocaine) | The primary clinical outcome is number of cocaine-use days (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) during the outpatient treatment and follow-up phases of the study. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Treatment, fMRI, Outcomes