Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
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|ClinicalTrials.gov Identifier: NCT04982029|
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : July 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Drug: Cannabidiol 100 MG/ML [Epidiolex] Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The study is a double-blind, placebo-controlled, cross-over trial.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||This is a double-blind cross-over trial, in which the research staff and participants will be blinded.|
|Official Title:||Cannabidiol on reward-and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder: A Double-blind, Placebo-controlled, Cross-over Trial|
|Actual Study Start Date :||April 14, 2022|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||August 30, 2022|
Experimental: Cannabidiol 600mg
All subjects will receive 600mg of oral cannabidiol in a double-blind fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL. Following administration, a battery of tests will be conducted to examine reward- and stress-related neurocognitive processes.
Drug: Cannabidiol 100 MG/ML [Epidiolex]
Placebo Comparator: Placebo
All subjects will receive a matching placebo in a double-blind fashion. Following administration, a battery of tests will be conducted to examine the impact on reward- and stress-related neurocognitive processes.
- Change in Cue-reactivity [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]The primary outcomes is cue-induced cravings (Opioid Craving Scale).
- Change in Delayed discount [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]Monetary Choice Questionnaire will be used to calculate impulse decision making.
- Change in Decision making [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]Iowa Gambling Task will be used to assess impulsive decision-making.
- Change in Attentional bias [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]Visual probe task will be used to assess attentional bias to drug-related cues.
- Change in Stress-reactivity [ Time Frame: Visit 2 and 3 (at least 1 week apart) ]Physiologic and subjective stress will be assessed.
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): NCT04982029
|Contact: Joji Suzuki, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Joji Suzuki, MD|
|Principal Investigator: Joji Suzuki, MD|
|United States, Vermont|
|Rutland Medical Center||Recruiting|
|Rutland, Vermont, United States, 05701|
|Contact: Saeed Ahmed, MD 802-775-7111 sahmed@RRMC.org|