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Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

Primary Purpose

Cocaine-Related Disorders

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Topiramate + Cognitive Behavioral Therapy
Placebo + Cognitive Behavioral Therapy
Sponsored by
Bankole Johnson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine addiction, cocaine dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Current DSM-IV diagnosis of cocaine dependence Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters Seeking treatment for cocaine dependence At least one positive urine drug screen for cocaine at screen or baseline prior to randomization If female, a negative pregnancy test prior to study entry Agrees to use an effective method of contraception for the duration of the study Reads and writes English Willing to participate in behavioral treatment for cocaine dependence Exclusion Criteria: Current DSM-IV diagnosis of dependence on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana Physiological dependence on alcohol and requires medical detoxification Neurological or psychiatric disorders Any Axis 1 disorder that warrants treatment or would preclude safe participation Organic brain disease Dementia Bulimia and/or anorexia nervosa Seizure disorders or epilepsy Any disorder which would require ongoing treatment or which would make study agent compliance difficult History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to screening Serious medical illnesses Mandated by the court to obtain treatment for cocaine dependence Expected to relocate from the study area AIDS diagnosis HIV with a CD4 positive T cell count less than 500 mm Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be excluded Active syphilis that has not been treated, or refused treatment for syphilis Severe or life-threatening adverse reactions to medications (including topiramate) in the past or during this clinical trial Currently receiving active treatment with topiramate Use of a drug with known potential for toxicity to a major organ system (e.g., isoniazid, methotrexate), within 30 days prior to study entry Pregnant or breastfeeding Concurrent regular use of psychotropics, including but not limited to antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to screening Clinically significant test results that, in the investigator's opinion, require immediate or urgent treatment Fever of unknown origin or neuroleptic malignant syndrome Serious medical co-morbidity requiring medical intervention or close supervision Received inpatient or outpatient treatment for cocaine dependence within the 4 weeks prior to study entry Past participation in a clinical trial utilizing topiramate Treatment with electroconvulsive therapy within the 3 months prior to study entry Member of the same household of an individual enrolled in the present study

Sites / Locations

  • UVA CARE
  • UVA CARE Richmond

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine).

Secondary Outcome Measures

Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

Full Information

First Posted
November 3, 2005
Last Updated
March 6, 2012
Sponsor
Bankole Johnson
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00249691
Brief Title
Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1
Official Title
Medication Development for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bankole Johnson
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.
Detailed Description
Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals. Participants will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks. Follow-up visits will occur at 2 weeks and 1, 2, and 3 months following completion of treatment, and will include evaluations of cocaine use and psychosocial functioning.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Topiramate + Cognitive Behavioral Therapy
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate up to 300 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo + Cognitive Behavioral Therapy
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo twice a day
Primary Outcome Measure Information:
Title
Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine).
Time Frame
Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)
Secondary Outcome Measure Information:
Title
Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
Time Frame
measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current DSM-IV diagnosis of cocaine dependence Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters Seeking treatment for cocaine dependence At least one positive urine drug screen for cocaine at screen or baseline prior to randomization If female, a negative pregnancy test prior to study entry Agrees to use an effective method of contraception for the duration of the study Reads and writes English Willing to participate in behavioral treatment for cocaine dependence Exclusion Criteria: Current DSM-IV diagnosis of dependence on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana Physiological dependence on alcohol and requires medical detoxification Neurological or psychiatric disorders Any Axis 1 disorder that warrants treatment or would preclude safe participation Organic brain disease Dementia Bulimia and/or anorexia nervosa Seizure disorders or epilepsy Any disorder which would require ongoing treatment or which would make study agent compliance difficult History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to screening Serious medical illnesses Mandated by the court to obtain treatment for cocaine dependence Expected to relocate from the study area AIDS diagnosis HIV with a CD4 positive T cell count less than 500 mm Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be excluded Active syphilis that has not been treated, or refused treatment for syphilis Severe or life-threatening adverse reactions to medications (including topiramate) in the past or during this clinical trial Currently receiving active treatment with topiramate Use of a drug with known potential for toxicity to a major organ system (e.g., isoniazid, methotrexate), within 30 days prior to study entry Pregnant or breastfeeding Concurrent regular use of psychotropics, including but not limited to antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to screening Clinically significant test results that, in the investigator's opinion, require immediate or urgent treatment Fever of unknown origin or neuroleptic malignant syndrome Serious medical co-morbidity requiring medical intervention or close supervision Received inpatient or outpatient treatment for cocaine dependence within the 4 weeks prior to study entry Past participation in a clinical trial utilizing topiramate Treatment with electroconvulsive therapy within the 3 months prior to study entry Member of the same household of an individual enrolled in the present study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA CARE
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
UVA CARE Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32880105
Citation
Khalifa NR, Gibbon S, Vollm BA, Cheung NH, McCarthy L. Pharmacological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007667. doi: 10.1002/14651858.CD007667.pub3.
Results Reference
derived
PubMed Identifier
24132249
Citation
Johnson BA, Ait-Daoud N, Wang XQ, Penberthy JK, Javors MA, Seneviratne C, Liu L. Topiramate for the treatment of cocaine addiction: a randomized clinical trial. JAMA Psychiatry. 2013 Dec;70(12):1338-46. doi: 10.1001/jamapsychiatry.2013.2295.
Results Reference
derived

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Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

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