Topiramate to Reduce Cocaine Dependence

NCT00223626 | Completed Phase 2 DMC

• 3 other identifiers: 12350R01DA012191DPMCDA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to determine the effectiveness of topiramate in reducing cocaine's rewarding effects in individuals addicted to cocaine.

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Addiction; Cocaine Dependence

Outcome Measures

Primary Outcomes (4)

• Cocaine-induced mood changes

  measured throughout cocaine and topiramate testing sessions

• Effects of topiramate on cognitive function

  measured throughout cocaine and topiramate testing sessions

• Drug safety

  measured throughout cocaine and topiramate testing sessions

• Cardiovascular response to cocaine (measured throughout cocaine and topiramate testing sessions)

  measured throughout cocaine and topiramate testing sessions

Secondary Outcomes (1)

• Physiological response (measured throughout cocaine and topiramate testing sessions)

  measured throughout cocaine and topiramate testing sessions

Study Arms (2)

Topiramate

EXPERIMENTAL

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

Drug: Topiramate

Interventions

Topiramate DRUG

the maximum topiramate test dose is 200 mg/d.

Also known as: Topamax

Placebo; Topiramate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-IV-TRTM diagnostic criteria for cocaine dependence
• Subjects must be non-treatment seeking, cocaine-dependent or cocaine-abusing individuals who report taking cocaine at least once a month
• In generally good health as confirmed by medical history, physical examination, electrocardiogram, laboratory screening tests, and vital signs
• Must be able to take oral medication, adhere to the medication regimens, and be willing to return to the clinic for regular study visits
• Must be able to read and understand all instructions, rating scales, and questionnaires in English
• Must be willing to stay overnight at the University Clinical Psychopharmacology Laboratory (UCPL)
• Must comply with the alcohol, tobacco, and drug-free environment regulations at the UCPL
• If female, must be postmenopausal for at least 1 year, surgically sterile, or willing to use contraception throughout the study

You may not qualify if:

• History of mental illness, other than cocaine or nicotine dependence
• History of mental retardation or neuropsychological functioning greater than 1.5 standard deviation below expected rang.
• Clinically significant abnormalities found on the electrocardiogram
• History of hypertension (blood pressure greater than 140/90 mm Hg) or systolic hypotension (blood pressure less than 90/75 mm Hg)
• Resting pulse rate of greater than 90 beats per minute
• Cerebrovascular accident or transient ischemic attack
• Ischemic heart disease or heart attack
• Symptomatic coronary artery disease or peripheral vascular disease
• Cancer or history of cancer within the 5 years of study entry (other than basal cell carcinoma)
• Kidney disease and/or impaired kidney function, as defined by an estimated creatinine clearance of 60 mL per minute
• Gastrointestinal system disease, including active liver disease or current active hepatitis; subjects with AST and/or ALT levels greater than four times the upper limit of the normal range and/or an increased total serum bilirubin level greater than two times the upper limit of normal at screening
• Endocrinological disorders, including thyroid disorders
• Glaucoma
• Gross neurological disorders, including seizure disorders and progressive or degenerative neurological disorders (e.g., multiple sclerosis)
• History of nephrolithiasis

Sponsors & Collaborators

• Bankole Johnson: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Virginia CARE Center for Addiction Research & Education

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Bankole A. Johnson, DSc,MD.PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Psychiatry and Neurobehavioral Sciences

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

US (2)