Clinical Trial of Topiramate for Cocaine Addiction

NCT00685178 | Completed Phase 2 Results DMC

• 1 other identifier: R01DA021808
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment. The study aims to answer whether topiramate

1. 1.is safe and acceptable to methadone patients
2. 2.reduces cocaine use
3. 3.helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive performance.

Conditions

Cocaine Dependence

Keywords

addiction; drug dependence; stimulant

Outcome Measures

Primary Outcomes (1)

• Proportion of Cocaine Positive Urine Samples Per Treatment Condition

  Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)

  Urine samples collected 3 times weekly from week 1 through 26

Secondary Outcomes (1)

• Voucher Earnings

  12 weeks (Weeks 8-20)

Study Arms (4)

1 topiramate + CR

EXPERIMENTAL

topiramate and contingency reinforcement for urine sample confirming cocaine abstinence

Drug: topiramate; Behavioral: Contingency Reinforcement

2 topiramate + NonCR

EXPERIMENTAL

Topiramate and random reinforcement irrespective of cocaine use

Drug: topiramate

4 Placebo + NonCR

PLACEBO COMPARATOR

Drug: placebo + NonCR

3 Placebo + CR

ACTIVE COMPARATOR

Placebo and contingency reinforcement for urine sample confirming cocaine abstinence

Behavioral: Contingency Reinforcement

Interventions

topiramate DRUG

topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day. capsules are administered from week 4 through 25 of the trial

Also known as: topamax®, CAS 97240-79-4

1 topiramate + CR; 2 topiramate + NonCR

Contingency Reinforcement BEHAVIORAL

monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

Also known as: contingency management

1 topiramate + CR; 3 Placebo + CR

placebo + NonCR DRUG

participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence

4 Placebo + NonCR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• active opioid and cocaine dependence
• seeking treatment for cocaine and opioid dependence
• eligible for methadone maintenance per state and federal regulations
• able and willing to provide a urine sample thrice a week
• willing to answer questionnaires on a weekly basis
• willing to provide breath samples for presence of alcohol thrice weekly
• fluent in the English language

You may not qualify if:

• allergy to sulfonamide drugs
• diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to a risk of acidosis
• history of nephrolithiasis
• HIV positive individuals who meet AIDS criteria by CDC criteria or are taking antiretroviral medications
• serious psychiatric illness (psychosis, dementia)
• glaucoma or family history of glaucoma
• prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine samples on demand
• female participants: being pregnant, lactating, or unwilling to use an effective method of contraception
• use of antiepileptic agents
• benzodiazepine dependence
• latex allergy

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Umbricht A, DeFulio A, Winstanley EL, Tompkins DA, Peirce J, Mintzer MZ, Strain EC, Bigelow GE. Topiramate for cocaine dependence during methadone maintenance treatment: a randomized controlled trial. Drug Alcohol Depend. 2014 Jul 1;140:92-100. doi: 10.1016/j.drugalcdep.2014.03.033. Epub 2014 Apr 16.

  PMID: 24814607 DERIVED

Related Links

• Umbricht A∗, DeFulio A, Winstanley EL, Tompkins DA, Peirce J, Mintzer MZ, Strain EC, Bigelow GE (2014) Topiramate for cocaine dependence during methadone maintenance treatment: a randomized controlled trial Drug and Alcohol Dependence 140:92-100

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive; Substance-Related Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Dr. Annie Umbricht
• Organization: Johns Hopkins University

annieumbricht@jhu.edu

410-550-1917

Study Officials

• Annie Umbricht, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 23, 2008
• First Posted: May 28, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)