A Study to Evaluate Treatment of Delayed Sleep-Wake Phase Syndrome with Melatonin in Patients with Comorbid Alcohol Use Disorders
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005329
Sponsor Protocol Number: 19-005329
About this study
The purposes of this study are to demonstrate the feasibility of assessing delayed dim light melatonin onset (DLMO) in patients with comorbid AUD and DSWPD utilizing a combination of questionnaires and laboratory assay of salivary melatonin levels, and to examine the impact of low-dose melatonin on SOL and overall sleep quality in patients withcomorbid AUD and DSWPD with delayed DLMO compared to those without delayed DLMO.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subjects 18 years or older admitted to the IAP, an outpatient addiction treatment program.
- Primary diagnosis of moderate to severe Alcohol Use Disorder.
- If the subject qualifies for the CRU visit, they must agree to abstain from caffeine during the CRU visit to proceed.
Exclusion Criteria:
- Currently on melatonin and unwilling to discontinue at least 2 weeks prior to completing the CRU visit.
- Currently on hypnotic medications (benzodiazepines and trazadone) and unwilling to discontinue for 5 days prior to the CRU visit and for the duration of the study if they meet requirements and begin melatonin treatment following the CRU visit.
- Unable or unwilling to provide informed consent.
- Pregnant or considering pregnancy.
- Diagnosis of any SUD, other than alcohol and mild cannabis use disorder, that has been active in the past 30 days.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bhanuprakash Kolla, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available