Methamphetamine Dependence
Conditions
Keywords
Methamphetamine Dependence
Brief summary
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Detailed description
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
Interventions
DRUGModafinil
200 mg or 400 mg /daily
DRUGPlacebo
Placebo / daily
Sponsors
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be between the ages of 18 and 65 * Methamphetamine dependent as defined by DSM-IV criteria * Must be in good general heath with a history of methamphetamine use at screening * Must be able to provide written informed consent * If female and of child bearing potential, must agree to use birth control.
Exclusion criteria
* Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence (Week 1 - 12) | Weeks 1 - 12 | Number of participant who abstained from methamphetamine from weeks 1 through 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Craving | 21 days | Number of subjects with 21 or more consecutive days of abstinence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Modafinil Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily | 142 |
| Placebo Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily | 68 |
| Total | 210 |
Baseline characteristics
| Characteristic | Modafinil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 17.3 | 39 years STANDARD_DEVIATION 8.6 | 39 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 142 participants | 68 participants | 210 participants |
| Sex: Female, Male Female | 56 Participants | 30 Participants | 86 Participants |
| Sex: Female, Male Male | 86 Participants | 38 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 128 / 142 | 54 / 68 |
| serious Total, serious adverse events | 0 / 142 | 5 / 68 |
Outcome results
Primary
Abstinence (Week 1 - 12)
Number of participant who abstained from methamphetamine from weeks 1 through 12
Time frame: Weeks 1 - 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil | Abstinence (Week 1 - 12) | Week 9 | 35 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 2 | 38 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 3 | 39 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 4 | 46 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 5 | 41 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 6 | 39 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 7 | 34 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 10 | 34 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 11 | 37 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 12 | 34 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 8 | 40 Participants |
| Modafinil | Abstinence (Week 1 - 12) | Week 1 | 27 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 8 | 16 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 1 | 14 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 9 | 17 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 2 | 13 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 12 | 17 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 3 | 13 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 10 | 14 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 4 | 15 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 7 | 14 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 5 | 16 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 11 | 16 Participants |
| Placebo | Abstinence (Week 1 - 12) | Week 6 | 15 Participants |
Secondary
Reduction of Craving
Number of subjects with 21 or more consecutive days of abstinence
Time frame: 21 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modafinil | Reduction of Craving | 32 Participants |
| Placebo | Reduction of Craving | 10 Participants |