# Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

> **NIH NIH UG3** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2022 · $1,083,127

## Abstract

Project Summary/Abstract:
In response to the national public health crisis of opioid misuse and addiction, the National
Institute of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative in
April 2018 to aggressively drive the development of scientific tools that will end the opioid crisis
by accelerating effective discoveries through the FDA for drug approval. The HEAL Initiative
development programs over the next five years are expected to result in 15 Investigational New
Drugs (INDs) applications and at least 5 New Drug Applications (NDAs). The NIH HEAL
Initiative has issued this RFA-DA-19-002 under the National Institute on Drug Abuse (NIDA) to
“support the discovery and development of medications to prevent and treat opioid use
disorders (OUD) and overdose.”
INSYS Development Company, Inc. (INSYS) has developed cannabidiol oral solution, which
shows promise as a novel medication for prevention of relapse that addresses one of the five
opportunities specified to improve treatment options (Opportunity 4). INSYS, in collaboration
with KAI Research, Inc., plans to initiate the clinical develop program of Cannabidiol Effects
on Craving and Relapse Prevention in Opioid Use Disorder consisting of three proposed
clinical trials under the UG3/UH3 Phases:
1. For the UG3 phase, INSYS in collaboration with principal investigator Edythe London, PhD
 (UCLA) will conduct a randomized, double-blind, placebo controlled, dose-ranging study of
 cannabidiol oral solution on cue-induced cravings, modulation of withdrawal, alteration in
 negative affect states, relapse to opioid use, and treatment retention in patients with OUD
 receiving buprenorphine treatment in a residential drug treatment facility. The findings from
 this study will be used to support the transition to the UH3 phase.
2. For the UH3 phase, INSYS in collaboration with principal investigator Kathleen Brady, MD,
 PhD (MUSC) will conduct two studies in an outpatient setting:
 • A randomized, double-blind, placebo-controlled, parallel-group study of cannabidiol oral
 capsule as adjunctive therapy to buprenorphine ± naloxone for treatment in patients with
 opioid use disorder.
 • A randomized, double-blind, active-controlled, parallel-group, double-dummy, proof-of-
 concept study of cannabidiol oral capsule compared to naltrexone as monotherapy for
 treatment in patients with opioid use disorder.

## Key facts

- **NIH application ID:** 9926864
- **Project number:** 5UG3DA048388-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Edythe Danick London
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,083,127
- **Award type:** 5
- **Project period:** 2019-05-15 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9926864

## Citation

> US National Institutes of Health, RePORTER application 9926864, Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder (5UG3DA048388-03). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9926864. Licensed CC0.

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