A Study of Baclofen ER

NCT ID: NCT02003664

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Baclofen ER versus Placebo

Baclofen ER versus Placebo (sugar pill)

Group Type: ACTIVE_COMPARATOR

Baclofen ER

Intervention Type: DRUG

Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication

Placebo versus Baclofen ER

Participants will receive either placebo (sugar pill) or Baclofen ER

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo

Interventions

Baclofen ER

Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication

Intervention Type: DRUG

Placebo

Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo

Intervention Type: DRUG

Other Intervention Names

Sugar pill

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Rose Childress, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center for the Studies of Addiction

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

819017

Identifier Type: -

Identifier Source: org_study_id