Methamphetamine Dependence, Treatment Seeking
Conditions
Keywords
methamphetamine, crystal, treatment
Brief summary
This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.
Interventions
DRUGAcamprosate
2 gr/day (333 mg, TID)
DRUGplacebo
matching placebo
Sponsors
Forest Laboratories
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Methamphetamine dependence * Treatment seeking * Urine sample (+) for methamphetamine
Exclusion criteria
* Pregnancy * Dependence on other drugs (except nicotine) * DSM-IV axis I disorder unrelated to drug abuse * Serious medical condition in clinicians opinion. * AIDs * Untreated syphilis * Allergy to acamprosate * Methadone, or other ORP, maintenance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Methamphetamine Abstinence | 7 day |
Secondary
| Measure | Time frame |
|---|---|
| Craving | 7 day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acamprosate Acamprosate: 2 gr/day (333 mg, TID) | 36 |
| Placebo placebo: matching placebo | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completion unknown | 36 | 36 |
Baseline characteristics
| Characteristic | Acamprosate | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Methamphetamine Abstinence
Time frame: 7 day
Population: PI passed away, data is unavailable.
Secondary
Craving
Time frame: 7 day
Population: PI passed away, data is unavailable