NCT00249691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

6 years

First QC Date

November 3, 2005

Last Update Submit

March 6, 2012

Conditions

Cocaine-Related Disorders

Keywords

cocaine addictioncocaine dependence

Outcome Measures

Primary Outcomes (1)

  • 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).

    Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)

Secondary Outcomes (1)

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

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

Study Arms (2)

Topiramate

EXPERIMENTAL
Drug: Topiramate + Cognitive Behavioral Therapy

Placebo

PLACEBO COMPARATOR
Drug: Placebo + Cognitive Behavioral Therapy

Interventions

Topiramate + Cognitive Behavioral TherapyDRUG

Topiramate up to 300 mg per day

Also known as: Topamax
Topiramate
Placebo + Cognitive Behavioral TherapyDRUG

Placebo twice a day

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

Related Publications (2)

  • 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.

    PMID: 32880105DERIVED

  • 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.

    PMID: 24132249DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

TopiramateCognitive Behavioral TherapySugars

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesCarbohydratesKetosesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bankole Johnson

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair of Psychiatry and Neurobehavioral Sciences

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(2)