Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine
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|ClinicalTrials.gov Identifier: NCT05076370|
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : October 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Addiction||Drug: CBD Day 1 Drug: CBD Day 2 Drug: CBD Day 3||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.|
|Masking:||None (Open Label)|
|Official Title:||Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain|
|Actual Study Start Date :||December 8, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||July 30, 2023|
Active Comparator: CBD 400mg
Drug: CBD Day 1
Active Comparator: CBD 800mg
Drug: CBD Day 2
Active Comparator: CBD 1200mg
Drug: CBD Day 3
- Agitation Calmness Evaluation Scale (ACES) [ Time Frame: 8 hours ]The ACES consists of a single item that rates overall agitation and sedation of the participant at the time of evaluation, where 1 indicates marked agitation; 2: moderate agitation; 3: mild agitation; 4: normal behavior; 5: mild calmness; 6: moderate calmness; 7: marked calmness; 8: deep sleep; and 9: unarousable. Clinically significant sedation was a priori defined as an ACES score of 7 (marked calmness) or higher at any point during the session.
- Mini Mental Status Examination (MMSE) [ Time Frame: 8 hours ]The MMSE is a 30-point scale that measures five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The MMSE is used extensively in clinical and research settings to measure cognitive impairment. A score of 23 or lower is indicative of cognitive impairment.
- Systematic Assessment of Side Effects (SAFTEE) [ Time Frame: 8 hours ]The SAFTEE is a multi-symptom checklist that has been used successfully in our previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE was administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4.5 hours after the administration of CBD (timepoint +240 minutes) during each test session. We did not observe evidence of "confusion", "fatigue", "inability to respond to things", "slowed thinking", "dizziness/lightheadedness", "weakness", "slowed movements", or "lack of coordination".
- Quantitative Sensory Testing (QST) [ Time Frame: 8 hours ]Pain will be assessed using a comprehensive QST battery
- The Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14) [ Time Frame: 8 hours ]The HCQ-14 consists of 14 statements about the respondent's feelings and thoughts about using heroin as he or she is completing the questionnaire (i.e., right now).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076370
|Contact: Joao De Aquino, M.D.||203-932-5711 ext 2916||Joao.firstname.lastname@example.org|
|Contact: Mehmet Sofuoglu, M.D.,Ph.D.||203-932-5711 ext email@example.com|
|United States, Connecticut|
|Veteran Affairs Hospital||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Brendan Sullivan 203-932-5711 ext 3350 firstname.lastname@example.org|
|Principal Investigator: Joao De Aquino, M.D.|
|Principal Investigator:||Joao De Aquino, M.D.||Yale University|