A Phase 2 interventional study of Modafinil and Placebo in Methamphetamine Dependence, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment
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.
University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Drug: Modafinil
Placebo
Drug: Placebo
400 mg/day
inactive substance
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
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.
| Milestone | Modafinil | Placebo |
|---|---|---|
| Started | 6 | 3 |
| Completed | 1 | 1 |
| Not completed | 5 | 2 |
| Withdrew: Withdrawal by subject | 4 | 1 |
| Withdrew: Physician decision | 1 | 1 |
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.
| scores on a scale | Placebo | Modafinil |
|---|---|---|
| Mean Treatment Effectiveness Scores | 0.5625 ± 0.38 | .333 ± .31 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modafinil | — | 0/6 (0%) | 4/6 (66.7%) |
| Placebo | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | Modafinil | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 2/6 | 2/3 |
| InsomniaPsychiatric disorders | 2/6 | 0/3 |
| NauseaGastrointestinal disorders | 0/6 | 1/3 |
| AnxietyPsychiatric disorders | 1/6 | 0/3 |
| Weight lossMetabolism and nutrition disorders | 1/6 | 0/3 |
| Age, Categorical(Participants) | Modafinil | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 3 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Modafinil | Placebo | Total |
|---|---|---|---|
| Mean | 29.25 ± 2.87 | 35.88 ± 12.15 | 32.56 ± 9.19 |
| Sex: Female, Male(Participants) | Modafinil | Placebo | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 3 | 2 | 5 |
| Region of Enrollment(participants) | Modafinil | Placebo | Total |
|---|---|---|---|
| United States | 6 | 3 | 9 |
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas