The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program

NCT02431728 | Completed Phase 1

• 1 other identifier: DuquesneU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Substance Withdrawal Syndrome

Keywords

Melatonin; Post-acute withdrawal symptoms; Anxiety; Depression; Insomnia; Stress; Substance withdrawal syndrome

Outcome Measures

Primary Outcomes (4)

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

  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."

  Baseline, Day 7, Day 14, Day 21, Day 28

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

  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.

  Baseline, Day 7, Day 14, Day 21, Day 28

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

  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.

  Baseline, Day 7, Day 14, Day 21, Day 28

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

  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.

  Baseline, Day 7, Day 14, Day 21, Day 28

Secondary Outcomes (2)

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

  Baseline

• The number of reported adverse effects

  Day 7, Day 14, Day 21, Day 28

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

capsule containing 5mg melatonin plus cellulose

Dietary Supplement: Melatonin

Matched Placebo

PLACEBO COMPARATOR

capsule containing cellulose

Dietary Supplement: Matched Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

5 mg capsule p.o. at bedtime daily

Also known as: N-acetyl-5-methoxytryptamine

Melatonin

Matched Placebo DIETARY_SUPPLEMENT

5 mg capsule p.o. at bedtime daily

Also known as: Vegetable fiber

Matched Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients already taking melatonin
• Adverse history with melatonin supplementation

Sponsors & Collaborators

• Duquesne University: lead

Study Sites (1)

Salvation Army Harbor Light Center

Pittsburgh, Pennsylvania, 15233, United States

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin; Dietary Fiber

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vincent Giannetti, Ph.D.

  Duquesne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)