Trial Outcomes & Findings for A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction (NCT NCT00571922)
NCT ID: NCT00571922
Last Updated: 2017-03-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
72 participants
Primary outcome timeframe
7 day
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
Acamprosate
Acamprosate: 2 gr/day (333 mg, TID)
|
Placebo
placebo: matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
36
|
Reasons for withdrawal
| Measure |
Acamprosate
Acamprosate: 2 gr/day (333 mg, TID)
|
Placebo
placebo: matching placebo
|
|---|---|---|
|
Overall Study
Completion unknown
|
36
|
36
|
Baseline Characteristics
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
placebo: matching placebo
|
Acamprosate
n=36 Participants
Acamprosate: 2 gr/day (333 mg, TID)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 dayPopulation: PI passed away, data is unavailable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 dayPopulation: PI passed away, data is unavailable
Outcome measures
Outcome data not reported
Adverse Events
Acamprosate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
The Office of Clinical Trials
NYU Langone Medical Center
Phone: 212.263.4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place