|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00395850 |
|
Date of registration:
|
02/11/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Disulfiram for Cocaine Abuse
|
|
Scientific title:
|
Disulfiram for Cocaine Abuse |
|
Date of first enrolment:
|
April 2007 |
|
Target sample size:
|
95 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00395850 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Alison Oliveto, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Arkansas |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- current users of cocaine, including having a cocaine-positive urine
- self-reported use of > 7 gm during the preceding 6 months and > 1 time/week in at
least one month preceding study entry
- meet DSM-IV criteria for cocaine dependence
Exclusion Criteria:
- current diagnosis of alcohol dependence
- significant medical conditions such as abnormal liver function
- active hepatitis
- hypertension
- a current cardiac condition or high risk of cardiovascular disease
- seizure disorders
- any another significant underlying medical condition which would contraindicate
disulfiram or methadone treatment
- meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or
other psychotic disorders
- exhibiting current suicidality or homicidality
- pregnancy
- current use of a prescribed psychotropic medication (e.g., antidepressants,
anxiolytics, antipsychotics, anticonvulsants, etc.) which cannot be discontinued
current use of medications such as anticoagulants, isoniazid, metronidazole,
clotrimazole, and paraldehyde.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cocaine Dependence
|
|
Intervention(s)
|
|
Drug: Disulfiram
|
|
Primary Outcome(s)
|
|
cocaine use as determined by urine toxicology screens
[Time Frame: 14 weeks]
|
|
Secondary Outcome(s)
|
|
retention
[Time Frame: 14 weeks]
|
|
Secondary ID(s)
|
|
1R01DA013441-01A1
|
|
5R01DA013441-02
|
|
5R01DA013441-03
|
|
5R01DA013441-04
|
|
5R01DA013441-06
|
|
5R01DA013441-08
|
|
5R01DA013441-09
|
|
5R01DA013441-10
|
|
7R01DA013441-05
|
|
DPMC
|
|
NIDA-13441
|
|
R01DA013441
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|