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Completed

NCT Number: NCT02431728

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 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.

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Key information

Conditions

Substance Withdrawal Syndrome Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Salvation Army Harbor Light Center

Pittsburgh, Pennsylvania, 15233, United States

About this study

Approval was obtained from the Institutional Review Board at Duquesne University prior to the study implementation. The trial was a single-center, randomized, double-blind, matched placebo-controlled, parallel-group trial conducted in males 18 years of age and older who are in a residential treatment program for chemical dependency at the Salvation Army Harbor Light Center (865 West North Avenue, Pittsburgh, Pennsylvania, 15233) in the United States of America. Convenience sampling was used to recruit individuals from July 2015 to December 2015. A total sample of 70 participants were enrolled and block randomized with an allocation ratio of 1:1 for the interventions. Financial compensation of $5.00 U.S. was initiated at Day 7 and continued at each follow-up (Day 14, Day 21 & Day 28). Intention-to-treat and complete case analyses were conducted. No interim analysis was performed to assess efficacy. Participants completed study materials in a designated room at the center.

Briefly, this study involved the completion of four validated surveys assessing self-reported perceived severity of anxiety (Generalized Anxiety Disorder Scale; GAD-7), depression (Personal Health Questionnaire Depression Scale; PHQ-8), stress (Perceived Stress Scale; PSS-14), sleep complaints and how is sleep affecting daily life (Pittsburgh Sleep Symptom Questionnaire - Insomnia; PSSQ-1) at five time points (Baseline, Day 7, Day 14, Day 21, and Day 28). To address any adverse events relating to the interventions, the participant was encouraged to report any perceived adverse events to the investigator. To protect the anonymity and confidentiality of the participants, all paperwork were de-identified but contained their unique identification number.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males 18 years of age and older who are actively participating in therapy at a residential treatment program
  • Willingness to participate in the 4-week study
  • Willingness to provide self-reported demographic, social, medical, medication, preventive, and mental health histories
  • Willingness to complete self-assessments of anxiety, depression, insomnia, and stress at designated time intervals
  • Willingness to administer daily before bed a capsule containing either 5 mg melatonin plus vegetable fiber filler or only the vegetable fiber filler without melatonin (i.e., the matched placebo).
  • English speaking

Exclusion criteria

  • Patients already taking melatonin
  • Adverse history with melatonin supplementation

Treatment and study plan

melatonin

Dietary Supplement

5 mg capsule p.o. at bedtime daily

Other names: N-acetyl-5-methoxytryptamine

Matched Placebo

Dietary Supplement

5 mg capsule p.o. at bedtime daily

Other names: Vegetable fiber

Primary outcomes

  1. The effect of melatonin or placebo on the change in anxiety as measured by the Generalized Anxiety Disorder (GAD-7) scale

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    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 activities of daily living, responses range from "Not difficult at all" to "Extremely difficult."

  2. The effect of melatonin or placebo on the change in depressive symptoms as measured by the Personal Health Questionnaire Depression Scale (PHQ-8)

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    The PHQ-8 assesses the perceived degree of depression through an 8-item scale that assesses if the individual indicates symptoms 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). The higher the sum total the greater the degree of depression; for example, a score of ≥20 is considered severe major depression.

  3. The effect of melatonin or placebo on the change in sleep symptoms as measured by the Pittsburgh Sleep Symptom Questionnaire - Insomnia (PSSQ-1)

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    It is a 13-item scale with two subscales: Sleep complaints and How sleep is affecting daily life and assesses their experience during the past month. It employs a six point scale to assess for "Sleep complaints" with response options "Never" (0 pts), "Do not know" (1 pt), "Rarely" (2 pts), "Sometimes" (3 pts), "Frequently" (4 pts) and "Always" (5 pts). It employs a five point scale to assess for "How sleep is affecting daily life," with the response options "Not at all" (0 pts), "A little bit" (1 pt), "Moderately" (2 pts), "Quite a bit (3 pts), and "Extremely" (4 pts). If all criterion questions result in a "Yes," then one can assign a diagnosis of insomnia disorder.

  4. The effect of melatonin or placebo on the change in stress as measured by the Perceived Stress Scale (PSS-14)

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    The PSS-14 assesses the perceived stress through a 14-item scale that asks about the thoughts and feelings of the individual during the past month. It employs a five point scale with the response options "Never" (0 pts), "Almost Never" (1 pt), "Sometimes" (2 pts), "Fairly Often (3 pts), and "Very Often" (4 pts). In scoring the scale, scores are obtained by reversing the scores on items 4, 5, 6, 7, 9, 10, and 13 because these questions are positively stated items. The scores are summed with higher score indicating more perceived stress.

Secondary outcomes

  1. Patient health histories (social, medical, medication, preventive, and mental health)

    Time frame: Baseline

    Patient health histories were used to collect key information that may be used to further identify relevant data that have the potential be used to formulate other studies that the self-reported scales do not assess. Also, the histories were used to measure the effect of confounding and moderating factors.

  2. The number of reported adverse effects

    Time frame: Day 7, Day 14, Day 21, Day 28

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Registry information

Official study title

The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program: A Randomized, Double Blind, Placebo, Controlled Trial

Acronym: M-PAWS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 1, 2015
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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