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Disulfiram for Cocaine Abuse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00395850
First received: November 2, 2006
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: March 14, 2013  
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
Condition: Cocaine Dependence
Intervention: Drug: Disulfiram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between April 2006 and September 2011. Opioid- or nonopioid dependent treatment seekers recruited via newspaper ads, radio ads, flyer, word-of-mouth and referrals and attended the Treatment Research Unit, initially located in an off-campus facility and then relocated to the the Psychiatric Research Institute (12/08).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent either a two-week induction onto methadone (if opioid dependent) or a two-week baseline period prior to randomization to the treatment arms and receiving medication starting in week 3. Those receiving at >1 dose of medication and completing assessments at at least 2 time points during week 3 were include in the analyses.

Reporting Groups
  Description
Placebo microcrystalline cellulose
Disulfiram 250 disulfiram at 250 mg/day
Disulfiram 375 Disulfiram at 375 mg/day
Disulfiram 500 Disulfiram at 500 mg/day

Participant Flow for 3 periods

Period 1:   Pre-randomization Baseline/Induction
    Placebo   Disulfiram 250   Disulfiram 375   Disulfiram 500
STARTED   118 [1]   0   0   0 
COMPLETED   107   0   0   0 
NOT COMPLETED   11   0   0   0 
noncompliance (missed med/urine)                6                0                0                0 
Withdrawal by Subject                4                0                0                0 
Inconsistent attendance                1                0                0                0 
[1] Pre-randomization and disulfiram (disulf) administration

Period 2:   Randomization to Disulfiram/ Pre-admin
    Placebo   Disulfiram 250   Disulfiram 375   Disulfiram 500
STARTED   27   25   30   25 
COMPLETED   22   23   24   21 
NOT COMPLETED   5   2   6   4 
noncompliance - missed med/urines                2                2                6                4 
noncompliance with alcohol use                1                0                0                0 
suicidal ideation                1                0                0                0 
work schedule conflict                1                0                0                0 

Period 3:   Disulfiram/Placebo Treatment
    Placebo   Disulfiram 250   Disulfiram 375   Disulfiram 500
STARTED   20 [1]   23 [2]   24 [2]   21 [2] 
COMPLETED   11   9   5   8 
NOT COMPLETED   9   14   19   13 
[1] Received >= 1 disulfiram dose. Two baseline/randomized subjects dropped out before receiving disulf
[2] Received at least one dose of disulfiram



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo microcrystalline cellulose
Disulfiram 250 disulfiram at 250 mg/day
Disulfiram 375 Disulfiram at 375 mg/day
Disulfiram 500 Disulfiram at 500 mg/day
Total Total of all reporting groups

Baseline Measures
   Placebo   Disulfiram 250   Disulfiram 375   Disulfiram 500   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   25   30   25   107 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   27   25   30   25   107 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.0  (12.4)   39.8  (11.3)   39.4  (10.1)   40.4  (10.1)   40.6  (11.0) 
Gender 
[Units: Participants]
         
Female   10   10   13   8   41 
Male   17   15   17   17   66 
Region of Enrollment 
[Units: Participants]
         
United States   27   25   30   25   107 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cocaine Use Over Time   [ Time Frame: thrice weekly for 12 weeks ]

2.  Secondary:   Retention   [ Time Frame: 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alison Oliveto
Organization: University of Arkansas for Medical Sciences
phone: 501-526-8441
e-mail: olivetoalison@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00395850     History of Changes
Other Study ID Numbers: NIDA-13441
5R01DA013441-02 ( US NIH Grant/Contract Award Number )
5R01DA013441-03 ( US NIH Grant/Contract Award Number )
5R01DA013441-04 ( US NIH Grant/Contract Award Number )
5R01DA013441-06 ( US NIH Grant/Contract Award Number )
1R01DA013441-01A1 ( US NIH Grant/Contract Award Number )
7R01DA013441-05 ( US NIH Grant/Contract Award Number )
5R01DA013441-09 ( US NIH Grant/Contract Award Number )
5R01DA013441-10 ( US NIH Grant/Contract Award Number )
5R01DA013441-08 ( US NIH Grant/Contract Award Number )
R01DA013441 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: November 2, 2006
Results First Received: March 14, 2013
Last Updated: September 6, 2013
Health Authority: United States: Food and Drug Administration