NCT00218608

Brief Summary

Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

5.8 years

First QC Date

September 20, 2005

Last Update Submit

January 26, 2012

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Keywords

Cocaine Abuse

Outcome Measures

Primary Outcomes (1)

  • Cocaine use

    Urine toxicology screens were conducted thrice-weekly for 14 weeks.

    14 wks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14.

Drug: Disulfiram

Disulfiram at 62.5 mg

ACTIVE COMPARATOR

Disulfiram at 62.5 mg was suspended in the methadone during weeks 3-14.

Drug: Disulfiram

Disulfiram at 125 mg

ACTIVE COMPARATOR

Disulfiram at 125 mg/day was suspended in methadone during weeks 3-14.

Drug: Disulfiram

Disulfiram at 250 mg

ACTIVE COMPARATOR

Disulfiram at 250 mg/day was suspended in methadone during weeks 3-14.

Drug: Disulfiram

Interventions

DisulfiramDRUG

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Also known as: Antabuse
Disulfiram at 125 mgDisulfiram at 250 mgDisulfiram at 62.5 mgPlacebo

Eligibility Criteria

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

You may qualify if:

  • History of cocaine use at least once a week during the month prior to study entry
  • Urine screen tests positive for cocaine
  • Meets DSM-IV criteria for opioid- and cocaine-dependence
  • Urine toxicology screen tests negative for benzodiazepines prior to beginning methadone treatment

You may not qualify if:

  • Current drug or alcohol dependence other than opiates, cocaine, or tobacco
  • Significant medical condition, such as abnormal liver function (with laboratory findings greater than three times normal), active hepatitis, or high blood pressure
  • Current cardiac condition
  • Occult coronary artery disease
  • At high risk for cardiovascular disease, seizure disorders, or any other significant underlying medical condition that may make treatment with disulfiram or methadone unsafe
  • Meets DSM-IV psychiatric diagnostic criteria for lifetime schizophrenia, bipolar disorder, or other psychotic disorders
  • Currently suicidal or homicidal
  • Currently taking a prescribed psychotropic medication that cannot be discontinued
  • Pregnant
  • Currently taking metronidazole or clotrimazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205 7911, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

DitiocarbThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsDisulfidesSulfidesSulfur Compounds

Study Officials

  • Alison Oliveto, PhD

    UAMS

    PRINCIPAL INVESTIGATOR

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

September 20, 2005

First Posted

September 22, 2005

Study Start

April 1, 2001

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)