Last updated: February 23, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Opioid Use Disorder
Treatment
Palmitoylethanolamide
Placebo
Clinical Study ID
NCT05480072
2022P001440
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 to 65
- DSM-5 diagnosis of OUD
- English speaking
- Receiving either buprenorphine or methadone for treatment of opioid use disorder forat least 3 consecutive months prior to enrollment
- Receiving a stable dose of buprenorphine or methadone for the duration of the study
- Agreeable to abstaining from using any cannabis or CBD products two weeks prior toenrollment in the study, and for the duration of the trial
- For women of childbearing potential: agreeable to use one of the following:
- hormonal methods, such as birth control pills, patches, injections, vaginalrings, or implants
- barrier methods (such as a condom or diaphragm) used with a spermicide (a foam,cream, or gel that kills sperm)
- intrauterine device (IUD)
- abstinence (no sex)
Exclusion
Exclusion Criteria:
- DSM-5 diagnosis of moderate-to-severe cannabis use disorder, alcohol use disorder,and/or psychostimulant use disorder [medical record review and health history form]
- Active, recurrent substance use within the last 3 months that will interfere withstudy participation and completion of study procedures [medical record review andhealth history form]
- History of psychotic, bipolar and schizoaffective disorders [medical record review andhealth history form]
- Lifetime psychiatric hospitalization or suicide attempt, as assessed by the healthhistory form
- Recent history (within 2 years) of major depressive disorder [health history form andclinical interview]
- Currently pregnant or breastfeeding (female only) [pregnancy test/ self-reported]
- History of autoimmune or chronic inflammatory diseases [health history form] Currentuse of medications known to alter inflammatory and immune response [health historyform] Raynaud's disease [health history form]
- BMI >45
- Hepatic liver enzymes greater than 3x upper normal limit
- Vital signs: HR ≤60 or ≥100, SBP ≤90 or ≥160, DBP ≤50 or ≥100, RR < 12 or > 20
- Recent history of clinically significant medical conditions including, but not limitedto, malignancy (and treatment for malignancy), HIV, immunological, endocrine (including uncontrolled diabetes or thyroid disease), renal, GI, or hematologicalabnormalities that are uncontrolled* [health history form and medical record review]
Study Design
Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Palmitoylethanolamide
Phase: 1
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2024
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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