NCT00913484

Brief Summary

The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2000

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

October 1, 2000

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

June 3, 2009

Last Update Submit

November 18, 2020

Conditions

Cocaine DependenceOpioid Dependency

Keywords

DisulfiramBuprenorphineCocaine dependenceOpioid dependenceDopamine-Beta-Hydroxylase

Outcome Measures

Primary Outcomes (1)

  • Cocaine abstinence

    12 weeks

Secondary Outcomes (1)

  • Opioid abstinence

    12 weeks

Study Arms (2)

Disulfiram

EXPERIMENTAL

Disulfiram 250 mg per day

Drug: Disulfiram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DisulfiramDRUG

Disulfiram 250 mg per day

Disulfiram
PlaceboDRUG

Placebo daily

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking adults ages 18 - 45.
  • Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
  • Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.

You may not qualify if:

  • Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
  • Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
  • Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT \> 3X normal) will also be excluded.
  • Presence of any of the following cardiovascular risk factors:
  • age \> 45 years
  • history of cocaine-related chest pain
  • systolic blood pressure \> 140 or diastolic blood pressure \> 90
  • evidence of ischemia or past myocardial infarction on EKG
  • significant family history of risk (first degree relative with myocardial infarction prior to age 60)
  • elevated cholesterol (\> 300 mg/dl), elevated LDL (\> 170 mg/dl) or low HDL (\< 20 mg/dl)
  • Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
  • Current suicide or homicide risk or current psychotic disorder.
  • Inability to read or understand the symptom checklists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The APT Foundation MRU

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, 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

  • Richard S. Schottenfeld, M.D.

    Yale University

    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
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

October 1, 2000

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

US(2)