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Trial record 12 of 46 for:    disulfiram

Disulfiram for Cocaine Abuse

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ClinicalTrials.gov Identifier: NCT00395850
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cocaine Dependence
Intervention Drug: Disulfiram
Enrollment 118
Recruitment Details 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 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.
Arm/Group Title Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Hide Arm/Group Description microcrystalline cellulose disulfiram at 250 mg/day Disulfiram at 375 mg/day Disulfiram at 500 mg/day
Period Title: Pre-randomization Baseline/Induction
Started 118 [1] 0 0 0
Completed 107 0 0 0
Not Completed 11 0 0 0
Reason Not Completed
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 Title: Randomization to Disulfiram/ Pre-admin
Started 27 25 30 25
Completed 22 23 24 21
Not Completed 5 2 6 4
Reason Not Completed
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 Title: Disulfiram/Placebo Treatment
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
Arm/Group Title Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500 Total
Hide Arm/Group Description microcrystalline cellulose disulfiram at 250 mg/day Disulfiram at 375 mg/day Disulfiram at 500 mg/day Total of all reporting groups
Overall Number of Baseline Participants 27 25 30 25 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 30 participants 25 participants 107 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
25
 100.0%
30
 100.0%
25
 100.0%
107
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 25 participants 30 participants 25 participants 107 participants
43.0  (12.4) 39.8  (11.3) 39.4  (10.1) 40.4  (10.1) 40.6  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 30 participants 25 participants 107 participants
Female
10
  37.0%
10
  40.0%
13
  43.3%
8
  32.0%
41
  38.3%
Male
17
  63.0%
15
  60.0%
17
  56.7%
17
  68.0%
66
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 25 participants 30 participants 25 participants 107 participants
27 25 30 25 107
1.Primary Outcome
Title Cocaine Use Over Time
Hide Description Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)
Time Frame thrice weekly for 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
number is based on those who participated long enough to have assessments completed at two time points during the disulfiram phase
Arm/Group Title Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Hide Arm/Group Description:
microcrystalline cellulose
disulfiram at 250 mg/day
Disulfiram at 375 mg/day
Disulfiram at 500 mg/day
Overall Number of Participants Analyzed 27 25 30 25
Measure Type: Number
Unit of Measure: slope (change in prob of coc-pos utox/d)
0.01 0.007 -0.01 0.007
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Disulfiram 250, Disulfiram 375, Disulfiram 500
Comments Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Repeated Measures Logistic Regression
Comments Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression
Method of Estimation Estimation Parameter Slope
Estimated Value -1.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Retention
Hide Description [Not Specified]
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
those who were entered the disulfiram phase,e tc.
Arm/Group Title Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Hide Arm/Group Description:
microcrystalline cellulose
disulfiram at 250 mg/day
Disulfiram at 375 mg/day
Disulfiram at 500 mg/day
Overall Number of Participants Analyzed 27 25 30 25
Mean (Standard Deviation)
Unit of Measure: Weeks
8.3  (5.4) 9.0  (4.9) 6.4  (4.7) 8.3  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Disulfiram 250, Disulfiram 375, Disulfiram 500
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Estimation Comments [Not Specified]
Time Frame 12 weeks (during disulfiram phase) plus 2 wk washout
Adverse Event Reporting Description although participants were out of the protocol at the end of week 14, because disulfiram could interact with alcohol for up to 2 weeks after stopping use, we continued to monitor participants during this time.
 
Arm/Group Title Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Hide Arm/Group Description microcrystalline cellulose disulfiram at 250 mg/day Disulfiram at 375 mg/day Disulfiram at 500 mg/day
All-Cause Mortality
Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      1/23 (4.35%)      1/24 (4.17%)      0/21 (0.00%)    
Cardiac disorders         
Acute COPD exacerbation   0/20 (0.00%)  0 1/23 (4.35%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders         
Spinal Abcess   0/20 (0.00%)  0 0/23 (0.00%)  0 1/24 (4.17%)  1 0/21 (0.00%)  0
Psychiatric disorders         
Suicidal ideation   1/20 (5.00%)  1 0/23 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Disulfiram 250 Disulfiram 375 Disulfiram 500
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      12/23 (52.17%)      10/24 (41.67%)      11/21 (52.38%)    
Cardiac disorders         
Increased Vital Signs (e.g., BP, HR)   1/20 (5.00%)  1 4/23 (17.39%)  5 2/24 (8.33%)  3 2/21 (9.52%)  2
Gastrointestinal disorders         
GI Distress (e.g., nausea, vomiting, etc.)   2/20 (10.00%)  2 7/23 (30.43%)  9 6/24 (25.00%)  8 6/21 (28.57%)  6
Dry mouth/Excessive Thirst   1/20 (5.00%)  1 2/23 (8.70%)  2 0/24 (0.00%)  0 0/21 (0.00%)  0
Constipation   0/20 (0.00%)  0 1/23 (4.35%)  1 0/24 (0.00%)  0 1/21 (4.76%)  2
General disorders         
Sweating   2/20 (10.00%)  2 3/23 (13.04%)  3 0/24 (0.00%)  0 1/21 (4.76%)  1
Metallic or Garlic Taste   2/20 (10.00%)  2 2/23 (8.70%)  2 2/24 (8.33%)  2 3/21 (14.29%)  3
Lethargy/Sedation   1/20 (5.00%)  1 1/23 (4.35%)  1 2/24 (8.33%)  2 3/21 (14.29%)  3
Musculoskeletal and connective tissue disorders         
Slurred speech   0/20 (0.00%)  0 0/23 (0.00%)  0 0/24 (0.00%)  0 2/21 (9.52%)  2
Nervous system disorders         
Headache   1/20 (5.00%)  2 3/23 (13.04%)  3 1/24 (4.17%)  2 1/21 (4.76%)  1
Psychiatric disorders         
Confusion   1/20 (5.00%)  1 0/23 (0.00%)  0 0/24 (0.00%)  0 2/21 (9.52%)  2
Anxiety/Nervousness   0/20 (0.00%)  0 2/23 (8.70%)  2 0/24 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alison Oliveto
Organization: University of Arkansas for Medical Sciences
Phone: 501-526-8441
EMail: olivetoalison@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00395850     History of Changes
Other Study ID Numbers: NIDA-13441
5R01DA013441-02 ( U.S. NIH Grant/Contract )
5R01DA013441-03 ( U.S. NIH Grant/Contract )
5R01DA013441-04 ( U.S. NIH Grant/Contract )
5R01DA013441-06 ( U.S. NIH Grant/Contract )
1R01DA013441-01A1 ( U.S. NIH Grant/Contract )
7R01DA013441-05 ( U.S. NIH Grant/Contract )
5R01DA013441-09 ( U.S. NIH Grant/Contract )
5R01DA013441-10 ( U.S. NIH Grant/Contract )
5R01DA013441-08 ( U.S. NIH Grant/Contract )
R01DA013441 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: November 2, 2006
First Posted: November 3, 2006
Results First Submitted: March 14, 2013
Results First Posted: November 13, 2013
Last Update Posted: November 13, 2013