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NCT02431728 · ClinicalTrials.gov registry record · Phase 1
The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
A Phase 1 study of Substance Withdrawal Syndrome, sponsored by Duquesne University.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT02431728: Completed Phase 1 study of Substance Withdrawal Syndrome, sponsored by Duquesne University.
NCT02431728 is a Phase 1 study of Substance Withdrawal Syndrome that has completed, run by Duquesne University. The registered enrollment target is 70 participants, below the 173-participant average among 3 other Substance Withdrawal Syndrome trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431728, a Phase 1 study of Substance Withdrawal Syndrome, has completed, sponsored by Duquesne University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals recovering from drug and/or alcohol addiction initially experience the symptoms of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS include a wide array of emotional and psychological symptoms such as anxiety, sleep disturbances, depression, and stress. Previous studies have shown that melatonin therapy was beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no randomized, double-blind, placebo controlled trials have been conducted in males who are experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms, insomnia, and stress in males with PAWS who reside in a residential treatment center.
Primary Outcome
The GAD-7 assesses the perceived severity of anxiety through a 7-item scale that assesses anxiety as measured by a symptom checklist over the last two weeks. It employs a four point scale with the response options "Not at all" (0 pts), "Several days" (1 pt), "More than half the days" (2 pts), and "Nearly every day (3 pts). Severity is based on the sum total where 15 - 21 is considered "severe anxiety". The GAD-7 also asks a question about how difficult have these problems contributed to the acti
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Melatonin
- DIETARY_SUPPLEMENT Matched Placebo
Study Locations (1)
Pennsylvania
- Salvation Army Harbor Light Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT02431728 record still lists
NCT02431728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 173-participant average among 3 other Substance Withdrawal Syndrome trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Substance Withdrawal Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Melatonin is the first listed.
NCT02431728 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02431728 about?
NCT02431728 is a clinical study titled "The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program". Individuals recovering from drug and/or alcohol addiction initially experience the symptoms of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS include a wide array of emotional and psychological symptoms such as anxiety, sleep disturbances, depression, and str...
What is the current status of trial NCT02431728?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2015-05. Estimated completion is 2016-01.
What conditions does trial NCT02431728 study?
This clinical trial studies the following conditions: Substance Withdrawal Syndrome.
What interventions are being tested in trial NCT02431728?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Matched Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02431728?
This trial is sponsored by Duquesne University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02431728 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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