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Disulfiram for Cocaine Abuse

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00395850     History of Changes
Other Study ID Numbers: NIDA-13441, 5R01DA013441-02, 5R01DA013441-03, 5R01DA013441-04, 5R01DA013441-06, 1R01DA013441-01A1, 7R01DA013441-05, 5R01DA013441-09, 5R01DA013441-10, 5R01DA013441-08, R01DA013441, DPMC
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