Trial Outcomes & Findings for Open-Label Disulfiram for Methamphetamine Dependence (NCT NCT00731133)

Last Updated: 2012-02-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Weekly for six weeks

Results posted on

2012-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Disulfiram Disulfiram at 250 mg daily
Overall Study STARTED	15
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Disulfiram Disulfiram at 250 mg daily
Overall Study Withdrawal by Subject	10

Baseline Characteristics

Open-Label Disulfiram for Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disulfiram n=15 Participants Disulfiram at 250 mg daily
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	35.93 years STANDARD_DEVIATION 9.29 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

PRIMARY outcome

Timeframe: Weekly for six weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Disulfiram 250 mg n=14 Participants
Side Effects Checklist	9.6515 units on a scale Standard Deviation 2.4750

SECONDARY outcome

Timeframe: thrice weekly for 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Disulfiram 250 mg n=14 Participants
Proportion of Amphetamine-positive Urine Samples	0.3639 proportion of urines positive for amphet Standard Deviation 0.1113

Adverse Events

Disulfiram

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Disulfiram n=15 participants at risk Disulfiram at 250 mg daily
Gastrointestinal disorders Nausea/Vomitting	28.6% 4/14 • Number of events 5 • 6 weeks
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • 6 weeks
Cardiac disorders Increased blood pressure	7.1% 1/14 • Number of events 1 • 6 weeks
Psychiatric disorders Confusion	7.1% 1/14 • Number of events 1 • 6 weeks
General disorders Sleepiness	7.1% 1/14 • Number of events 1 • 6 weeks
Gastrointestinal disorders Stomach Bloating	7.1% 1/14 • Number of events 1 • 6 weeks
Nervous system disorders Blurry vision	7.1% 1/14 • Number of events 1 • 6 weeks
General disorders Dizziness	7.1% 1/14 • Number of events 1 • 6 weeks
Psychiatric disorders Anxiety/Racing Heart	7.1% 1/14 • Number of events 1 • 6 weeks
Gastrointestinal disorders Metallic Taste	7.1% 1/14 • Number of events 1 • 6 weeks

Additional Information

Dr. Alison Oliveto

UAMS

Phone: 501-526-8441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place