Clinical Trials Logo

Clinical Trial Summary

The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.


Clinical Trial Description

In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06206291
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Ruthie Perez
Phone 212-585-4696
Email ruthie.perez@mssm.edu
Status Recruiting
Phase Phase 2
Start date October 4, 2023
Completion date October 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06021431 - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT N/A
Completed NCT06266572 - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment Phase 1
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT06200740 - Remotely Observed Methadone Evaluation N/A
Not yet recruiting NCT06441604 - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy Phase 2
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Completed NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder Phase 1
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02440256 - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial N/A
Completed NCT05587998 - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users. Phase 1
Terminated NCT04577144 - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting NCT06001437 - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT05546229 - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting NCT06416020 - Integrating MOUD in African American Community Settings (Better Together) N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Completed NCT05552040 - START NOW in the Treatment of Opioid Addicted Individuals N/A
Recruiting NCT05459922 - Adjunctive Bright Light Therapy for Opioid Use Disorder N/A
Recruiting NCT05343169 - Community-based Education, Navigation, and Support Intervention for Military Veterans N/A
Recruiting NCT06081985 - Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder N/A