Methamphetamine Dependence
Conditions
Brief summary
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.
Interventions
DRUGModafinil
400 mg/day
DRUGPlacebo
inactive substance
Sponsors
University of Arkansas
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 65 Years
Healthy volunteers
No
Inclusion criteria
18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000). * not currently enrolled in a treatment program * subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry * subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID) * women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.
Exclusion criteria
* current diagnosis of alcohol, opiate, or sedative physical dependence * ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder) * history of schizophrenia, or bipolar type I disorder * present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested * medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine or desipramine) * current suicidality or psychosis * Liver function tests (i.e., liver enzymes) greater than three times normal levels * pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Treatment Effectiveness Scores | thrice weekly from week 3 through week 8 | Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported. |
Countries
United States
Participant flow
Recruitment details
A total of 20 participants were recruited into the study between 5/26/2009 and 3/30/2010. However, only 9 participants entered the study with 11 dropping out during the consent or intake process. They were recruited from newspaper advertisements and word-of-mouth advertising and who meet the following criteria.
Participants by arm
| Arm | Count |
|---|---|
| Modafinil Modafinil 400mg orally once daily | 6 |
| Placebo Two placebo tablets orally once daily | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Placebo | Modafinil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Continuous | 35.88 years STANDARD_DEVIATION 12.15 | 29.25 years STANDARD_DEVIATION 2.87 | 32.56 years STANDARD_DEVIATION 9.19 |
| Region of Enrollment United States | 3 participants | 6 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 2 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
Mean Treatment Effectiveness Scores
Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.
Time frame: thrice weekly from week 3 through week 8
Population: Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Treatment Effectiveness Scores | 0.5625 scores on a scale | Standard Deviation 0.38 |
| Modafinil | Mean Treatment Effectiveness Scores | .333 scores on a scale | Standard Deviation 0.31 |