Substance Withdrawal SyndromePhase 1/2M-PAWSNCT02431728
The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
A Phase 1/2 study testing Melatonin in people with Substance Withdrawal Syndrome, run by Duquesne University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients already taking melatonin
- Adverse history with melatonin supplementation
Trial locations and contacts
1 site in 1 country.
United States1 site
Salvation Army Harbor Light Center
Pittsburgh, Pennsylvania, 15233
About this study
Official title: The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program: A Randomized, Double Blind, Placebo, Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Melatonin, Matched Placebo
- Keywords
- Melatonin, Post-acute withdrawal symptoms, Anxiety, Depression, Insomnia, Stress, Substance withdrawal syndrome
- Medical subject headings
- Substance Withdrawal Syndrome, Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Also called N-acetyl-5-methoxytryptamine
5 mg capsule p.o. at bedtime daily
Matched PlaceboDietary supplement
Also called Vegetable fiber
5 mg capsule p.o. at bedtime daily
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | capsule containing 5mg melatonin plus cellulose Receives: Dietary Supplement: Melatonin |
| Matched Placebo | Placebo comparator | capsule containing cellulose Receives: Dietary Supplement: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 7, Day 14, Day 21, Day 28
Secondary outcomes (2)
Patient health histories (social, medical, medication, preventive, and mental health)
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.
Measured: Baseline
The number of reported adverse effects
Measured: Day 7, Day 14, Day 21, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Giannetti, Ph.D., Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431728
- Sponsor's protocol ID
- DuquesneU
- Acronym
- M-PAWS
- Status last verified
- Aug 2015
- First submitted
- 28 Apr 2015
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All data were in aggregrate with no personal identification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program: A Randomized, Double Blind, Placebo, Controlled Trial
- ClinicalTrials.gov ID
- NCT02431728
- Acronym / sponsor ID
- M-PAWS / DuquesneU
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Melatonin, Post-acute withdrawal symptoms, Anxiety, Depression, Insomnia, Stress, Substance withdrawal syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Dietary Supplement: Melatonincapsule containing 5mg melatonin plus cellulose |
| Matched Placebo | Placebo comparator | Dietary Supplement: Matched Placebocapsule containing cellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients already taking melatonin
- Adverse history with melatonin supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: N-acetyl-5-methoxytryptamine5 mg capsule p.o. at bedtime daily | Dietary supplement | Melatonin |
| Matched PlaceboAlso: Vegetable fiber5 mg capsule p.o. at bedtime daily | Dietary supplement | Matched Placebo |
Primary outcome
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."
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.
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.
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.
2 secondary outcomes
Patient health histories (social, medical, medication, preventive, and mental health)
Time frame: Baseline
The number of reported adverse effects
Time frame: Day 7, Day 14, Day 21, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No. All data were in aggregrate with no personal identification.
Related trials for Substance Withdrawal Syndrome
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
RecruitingPhase 1
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Opioid Use Disorder
Not yet recruitingPhase 4
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
E Cigarette Use, Cessation, Tobacco
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Giannetti, Ph.D. principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melatonin in people with Substance Withdrawal Syndrome, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.