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A Study of Baclofen ER (CURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003664
Recruitment Status : Withdrawn (This study never started due to delays in medication development)
First Posted : December 6, 2013
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Baclofen ER Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 ER on Brain and Behavioral Outcomes in Cocaine Dependence
Study Start Date : November 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
Active Comparator: Baclofen ER versus Placebo
Baclofen ER versus Placebo (sugar pill)
Drug: Baclofen ER
Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication

Placebo Comparator: Placebo versus Baclofen ER
Participants will receive either placebo (sugar pill) or Baclofen ER
Drug: Placebo
Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo
Other Name: Sugar pill




Primary Outcome Measures :
  1. Urines positive for benzoylecgonine (BE), (a metabolite of cocaine) [ Time Frame: up to 24 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003664


Locations
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United States, Pennsylvania
Center for the Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Anna Rose Childress, PhD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02003664    
Other Study ID Numbers: 819017
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Keywords provided by University of Pennsylvania:
Cocaine
Treatment
fMRI
Outcomes
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action