A Study of Baclofen ER

NCT02003664 | Withdrawn Phase 2 DMC

• 1 other identifier: 819017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Cocaine; Treatment; fMRI; Outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Baclofen ER versus Placebo

ACTIVE COMPARATOR

Baclofen ER versus Placebo (sugar pill)

Drug: Baclofen ER

Placebo versus Baclofen ER

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Baclofen ER DRUG

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

Baclofen ER versus Placebo

Placebo DRUG

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

Also known as: Sugar pill

Placebo versus Baclofen ER

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for the Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Anna Rose Childress, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

US (1)