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The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3

Primary Purpose

Cocaine Abuse, Cocaine-Related Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Abuse focused on measuring addiction, crack, cocaine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets DSM-IV criteria for cocaine dependence History of smoked or intravenous cocaine use on average of at least once a week over a 6 month period Positive urine test for cocaine No current medical problems Normal electrocardiogram If female, willing to use contraception throughout the study Exclusion Criteria: Seeking treatment for cocaine dependence Current major psychiatric illness, including mood disorder, psychotic disorder, or anxiety disorder Current dependence on alcohol or any drugs other than cocaine or nicotine History of major medical illness, including liver disease, suspected or known cancer, thrombophlebitis, or other medical conditions that are considered unsafe for study participants by the investigator Known allergy to study medications Pregnant or breastfeeding

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pregabalin

Placebo

Arm Description

pregabalin compared to placebo

Placebo compared to pregabalin

Outcomes

Primary Outcome Measures

Analog rating scale for drug effects; measured during each experimental session
Physiological response to cocaine; measured during each experimental session

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
July 7, 2015
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142883
Brief Title
The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3
Official Title
The Effects of GABA Medications on Cocaine Responses in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Study has been completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
Detailed Description
GABA is an inhibitory neurotransmitter that is found primarily in the brain. High GABA levels result in low levels of dopamine, another neurotransmitter that is the brain's "feel good" chemical and which plays a primary role in cocaine drug addiction. Cravings for cocaine can be reduced by lowering dopamine levels. This makes GABA-altering medications a potential treatment for cocaine addiction. This study will involve five GABA enhancing medications: tiagabine, topiramate, valproic acid, baclofen, and progesterone. The purpose of the study is to evaluate the interaction between GABA medications and cocaine in terms of safety and craving responses. In turn, these findings may guide future cocaine pharmacotherapy trials. This 6-day inpatient study will begin with an orientation session to familiarize participants with study procedures. The evening of Day 1, all participants will receive placebo medication. On Days 2 through 4, participants will receive one of five GABA medications. The GABA medications will be given in gradually increasing doses to attain therapeutic levels while maintaining safety and minimizing side effects. Three experimental cocaine sessions will take place; one while the participants are receiving the placebo medication and two while the participants are receiving the GABA medications. During these sessions, cocaine will be administered intravenously in three increasing doses, each separated by 30-minute intervals. This will allow the participants' subjective and physiological responses during cocaine administration to return to baseline levels before the next dose. Blood will be drawn after each dose; heart rate, blood pressure, and an ECG will be monitored throughout the sessions. At the end of each session, questionnaires will be administered to assess the effects of cocaine and related mood states, as well as allow the participants to report any adverse events, depression, craving, or withdrawal symptoms. This study is now closed and published.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse, Cocaine-Related Disorders
Keywords
addiction, crack, cocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Active Comparator
Arm Description
pregabalin compared to placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo compared to pregabalin
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
lyrica
Intervention Description
pregabalin compared to placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
sugar pill compared to pregabalin
Primary Outcome Measure Information:
Title
Analog rating scale for drug effects; measured during each experimental session
Time Frame
one week
Title
Physiological response to cocaine; measured during each experimental session
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for cocaine dependence History of smoked or intravenous cocaine use on average of at least once a week over a 6 month period Positive urine test for cocaine No current medical problems Normal electrocardiogram If female, willing to use contraception throughout the study Exclusion Criteria: Seeking treatment for cocaine dependence Current major psychiatric illness, including mood disorder, psychotic disorder, or anxiety disorder Current dependence on alcohol or any drugs other than cocaine or nicotine History of major medical illness, including liver disease, suspected or known cancer, thrombophlebitis, or other medical conditions that are considered unsafe for study participants by the investigator Known allergy to study medications Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Kosten, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3

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