Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01215929 · ClinicalTrials.gov registry record · Phase 2
Studying Amphetamine Withdrawal in Humans
A Phase 2 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01215929 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 35 participants.
The verdict
NCT01215929, a Phase 2 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Methamphetamine use is very common in the US and is associated with serious medical and psychiatric problems. There has also been a significant increase in the number of patients entering treatment for methamphetamine dependence, however, no pharmacologic treatment has been identified as effective in treating methamphetamine addiction. Given that withdrawal from methamphetamine is thought to contribute to relapse to methamphetamine use during early treatment, it is important to examine potential pharmacologic agents for alleviating withdrawal. Thus, this study is designed to study methamphetamine withdrawal in humans. To this end, 30 methamphetamine dependent participants (ages 18-65 years) will be entered into a 4-week residential study. Urine samples will be obtained at baseline to ensure recent methamphetamine use. Intake assessments will include cognitive testing, standardized assessment of depression and anxiety, profile of mood states, methamphetamine selective severity assessment, methamphetamine withdrawal assessment, sleep quality and quantity, a pre-attentional measure and attentional measure. Upon admission to the residential facility, all study participants will be started on (20-30mg) long acting amphetamine/d-amphetamine and stabilized over the first 5 days. After stabilization participants will be randomized based on sex, amphetamine withdrawal questionnaire score, and methamphetamine selective severity assessment score to either continued treatment with amphetamine/d-amphetamine or placebo for 2 weeks. All subjects will then be placed on placebo for the last 7 days. The investigators hypothesis is that stopping amphetamine administration in methamphetamine dependent individuals will negatively impact mood, sleep and cognitive function in a time-limited fashion that may differ depending upon the measure and that attentional, but not pre-attentional, measures will be adversely affected in those receiving placebo compared to those maintained on amphetam
Interventions
- DRUG Placebo
- DRUG Dextroamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01215929
The ClinicalTrials.gov registry entry for NCT01215929 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01215929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01215929 about?
NCT01215929 is a clinical study titled "Studying Amphetamine Withdrawal in Humans". Methamphetamine use is very common in the US and is associated with serious medical and psychiatric problems. There has also been a significant increase in the number of patients entering treatment for methamphetamine dependence, however, no pharmacologic treatment has been identified as effective i...
What is the current status of trial NCT01215929?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2009-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01215929?
The interventions under investigation include: Placebo (DRUG), Dextroamphetamine (DRUG).
Who is sponsoring clinical trial NCT01215929?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.