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The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
NCT02431728 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431728
The ClinicalTrials.gov registry entry for NCT02431728 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duquesne University, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02431728 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02431728?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Matched Placebo (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02431728?
This trial is sponsored by Duquesne University, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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