Cocaine Dependence | A Study of Baclofen ER
Cocaine Dependence research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence. 2. 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. 3. Reading level at or above eighth grade. 4. Participants provide voluntary informed consent. 5. Smoking is primary route of cocaine administration. 6. Available for an inpatient stay. Exclusion Criteria: 1. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. 2. Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities. 3. 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. 4. 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. 5. Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes. 6. Current or prior gambling problems (assessed by participants self-report) 7. Non-removable skin patches 8. 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) 9. Have known or suspected hypersensitivity to baclofen. 10. Be taking baclofen for any reason currently or during the past year.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Baclofen ERComparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication
Drug:PlaceboComparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Baclofen ER versus PlaceboBaclofen ER versus Placebo (sugar pill)
Placebo versus Baclofen ERParticipants will receive either placebo (sugar pill) or Baclofen ER
Start Date: November 2013
Completed Date: November 2014
Phase: Phase 2
Primary Outcome: Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
Study sponsors, principal investigator, and references
Principal Investigator: Anna Rose Childress, PhD
Lead Sponsor: University of Pennsylvania