Methamphetamine
Conditions
Keywords
methamphetamine addiction
Brief summary
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
Interventions
DRUGTopiramate
DRUGPlacebo Oral Tablet
Sponsors
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 99 Years
Healthy volunteers
No
Inclusion criteria
* Treatment seeking individuals as the time of the study * Must be able to proved written informed consent * Must have a body mass index greater than 18 kg/m(2) * Must meet DSM-IV criteria for methamphetamine dependence * Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days * If female of child bearing potential, must agree to use birth control
Exclusion criteria
* Please contact the site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence (Weeks 6 - 12) | weeks 6 through 12 | The number of participants who abstained from methamphetamine from weeks 6 through 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence (Weeks 1 - 12) | Weeks 1 through 12 | Number of participants who abstained from methamphetamine from weeks 1 through 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topiramate Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate | 69 |
| Placebo Oral Tablet After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet | 71 |
| Total | 140 |
Baseline characteristics
| Characteristic | Total | Topiramate | Placebo Oral Tablet |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 8.62 | 38.4 years STANDARD_DEVIATION 8.83 | 37.5 years STANDARD_DEVIATION 8.47 |
| Region of Enrollment United States | 140 participants | 69 participants | 71 participants |
| Sex: Female, Male Female | 51 Participants | 28 Participants | 23 Participants |
| Sex: Female, Male Male | 89 Participants | 41 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 69 | 64 / 71 |
| serious Total, serious adverse events | 3 / 69 | 8 / 71 |
Outcome results
Primary
Abstinence (Weeks 6 - 12)
The number of participants who abstained from methamphetamine from weeks 6 through 12
Time frame: weeks 6 through 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topiramate | Abstinence (Weeks 6 - 12) | Week 8 | 46 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 10 | 38 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 7 | 43 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 11 | 36 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 9 | 40 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 12 | 34 Participants |
| Topiramate | Abstinence (Weeks 6 - 12) | Week 6 | 49 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 12 | 32 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 6 | 49 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 7 | 48 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 8 | 45 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 9 | 41 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 10 | 33 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 6 - 12) | Week 11 | 38 Participants |
Secondary
Abstinence (Weeks 1 - 12)
Number of participants who abstained from methamphetamine from weeks 1 through 12
Time frame: Weeks 1 through 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topiramate | Abstinence (Weeks 1 - 12) | Week 8 | 46 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 3 | 55 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 7 | 43 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 4 | 55 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 5 | 56 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 1 | 58 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 10 | 38 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 6 | 49 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 11 | 36 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 2 | 56 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 12 | 34 Participants |
| Topiramate | Abstinence (Weeks 1 - 12) | Week 9 | 40 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 12 | 32 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 5 | 51 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 6 | 49 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 7 | 48 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 8 | 45 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 1 | 53 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 2 | 50 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 3 | 50 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 4 | 50 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 9 | 41 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 10 | 33 Participants |
| Placebo Oral Tablet | Abstinence (Weeks 1 - 12) | Week 11 | 38 Participants |