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Trial record 7 of 46 for:    disulfiram

Open-Label Disulfiram for Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT00731133
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Methamphetamine Dependence
Intervention Drug: Disulfiram
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Disulfiram
Hide Arm/Group Description Disulfiram at 250 mg daily
Period Title: Overall Study
Started 15
Completed 5
Not Completed 10
Reason Not Completed
Withdrawal by Subject             10
Arm/Group Title Disulfiram
Hide Arm/Group Description Disulfiram at 250 mg daily
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
35.93  (9.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Side Effects Checklist
Hide Description It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.
Time Frame Weekly for six weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.
Arm/Group Title Disulfiram 250 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
9.6515  (2.4750)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Disulfiram 250 mg
Comments Open-label study testing for change in side-effects ratings over time (i.e., slope).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments 7,24
Method of Estimation Estimation Parameter Slope
Estimated Value 2.6466
Confidence Interval (2-Sided) 95%
.7858 to 4.5073
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9016
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Amphetamine-positive Urine Samples
Hide Description the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.
Time Frame thrice weekly for 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.
Arm/Group Title Disulfiram 250 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Least Squares Mean (Standard Deviation)
Unit of Measure: proportion of urines positive for amphet
0.3639  (0.1113)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Disulfiram 250 mg
Comments Open label study testing changes in amphetamine use over time (i.e., slope).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments 7,24
Method of Estimation Estimation Parameter Slope
Estimated Value -0.3730
Confidence Interval (2-Sided) 95%
-0.8075 to 0.06150
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2196
Estimation Comments [Not Specified]
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Disulfiram
Hide Arm/Group Description Disulfiram at 250 mg daily
All-Cause Mortality
Disulfiram
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Disulfiram
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Disulfiram
Affected / at Risk (%) # Events
Total   7/15 (46.67%)    
Cardiac disorders   
Increased blood pressure   1/14 (7.14%)  1
Gastrointestinal disorders   
Nausea/Vomitting   4/14 (28.57%)  5
Stomach Bloating   1/14 (7.14%)  1
Metallic Taste   1/14 (7.14%)  1
General disorders   
Sleepiness   1/14 (7.14%)  1
Dizziness   1/14 (7.14%)  1
Nervous system disorders   
Headache   2/14 (14.29%)  2
Blurry vision   1/14 (7.14%)  1
Psychiatric disorders   
Confusion   1/14 (7.14%)  1
Anxiety/Racing Heart   1/14 (7.14%)  1
Indicates events were collected by systematic assessment
Large dropout so few participants had data throughout the trial. No control group so cannot determine whether side effects were related to disulfiram or an artifact of participation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Alison Oliveto
Organization: UAMS
Phone: 501-526-8441
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00731133     History of Changes
Other Study ID Numbers: 5-P50-DA018197-105242
5P50DA018197 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: November 2, 2011
Results First Posted: February 27, 2012
Last Update Posted: February 27, 2012