Trial Outcomes & Findings for Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder (NCT NCT00721526)
NCT ID: NCT00721526
Last Updated: 2023-08-30
Results Overview
Completion of 16 weeks of disulfiram treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-08-30
Participant Flow
Participant milestones
| Measure |
Disulfiram Plus Lorazepam
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Received Study Medication
|
40
|
|
Overall Study
Completed Week 1 Follow-up
|
38
|
|
Overall Study
Completed Week 2 Follow-up
|
37
|
|
Overall Study
Completed Week 4 Follow-up
|
36
|
|
Overall Study
Completed Week 6 Follow-up
|
35
|
|
Overall Study
Completed Week 8 Follow-up
|
32
|
|
Overall Study
Completed Week 10 Follow-up
|
29
|
|
Overall Study
Completed Week 12 Follow-up
|
27
|
|
Overall Study
Completed Week 16 Follow-up
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Disulfiram Plus Lorazepam
n=41 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Age, Continuous
|
41.66 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
|
Baseline proportion abstinent days
|
0.32 Percent
STANDARD_DEVIATION 0.31 • n=5 Participants
|
|
Baseline drinks per drinking day
|
16.12 Standard Drinks
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Baseline estimated peak blood alcohol level
|
0.34 percent (mass/volume)
STANDARD_DEVIATION 0.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat
Completion of 16 weeks of disulfiram treatment
Outcome measures
| Measure |
Disulfiram Plus Lorazepam
n=41 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Treatment Adherence
|
15 Participants
|
SECONDARY outcome
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)Population: Intent-to-treat sample (Baseline value imputed for missing values)
As measured by Timeline Followback
Outcome measures
| Measure |
Disulfiram Plus Lorazepam
n=41 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
|
65.14 percentage of days abstinent
Standard Deviation 41.004
|
SECONDARY outcome
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)Population: Percentage of 41 participants observed to be abstinent at week 16 (missing treated as non-abstinent)
As measured by timeline followback
Outcome measures
| Measure |
Disulfiram Plus Lorazepam
n=41 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Categorical Abstinence (Intent-to-treat Sample)
|
18 Participants
|
SECONDARY outcome
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)Population: Participants observed at week 16
As measured by Timeline Followback
Outcome measures
| Measure |
Disulfiram Plus Lorazepam
n=26 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
|
87.00 Percent
Standard Deviation 29.569
|
SECONDARY outcome
Timeframe: Weeks 13-16 (Last 4 weeks of treatment)Population: observed at week 16
As measured by timeline followback
Outcome measures
| Measure |
Disulfiram Plus Lorazepam
n=26 Participants
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Categorical Abstinence (Among Those Observed at Week 16)
|
18 Participants
|
Adverse Events
Disulfiram Plus Lorazepam
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Disulfiram Plus Lorazepam
n=40 participants at risk
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
Other adverse events
| Measure |
Disulfiram Plus Lorazepam
n=40 participants at risk
Disulfiram plus lorazepam
disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
General disorders
Asthenia
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
General disorders
Pain
|
7.5%
3/40 • Number of events 3 • 24 weeks following first administration of study medication
|
|
Infections and infestations
Candida infection
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Infections and infestations
Tooth abscess
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Injury, poisoning and procedural complications
Concussion
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Investigations
Transaminases increased
|
7.5%
3/40 • Number of events 3 • 24 weeks following first administration of study medication
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
30.0%
12/40 • Number of events 15 • 24 weeks following first administration of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • Number of events 3 • 24 weeks following first administration of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Psychiatric disorders
Apathy
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Psychiatric disorders
Feelings of worthlessness
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2 • 24 weeks following first administration of study medication
|
|
Psychiatric disorders
Panic attack
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Renal and urinary disorders
Micturition urgency
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Renal and urinary disorders
Pollakiuria
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
|
Surgical and medical procedures
Bunion operation
|
2.5%
1/40 • Number of events 1 • 24 weeks following first administration of study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place