# Hemp-derived Cannabidiol for the treatment of cannabis use disorder in concentrate users: A double-blind placebo-controlled randomized trial

> **NIH NIH R01** · UNIVERSITY OF COLORADO · 2024 · $98,952

## Abstract

Project Summary
As cannabis legalization continues to spread across the United States, average Δ9-tetrahydrocannabinol (THC)
concentrations in recreational products have significantly increased, with THC levels as high as 90-95%. Our
preliminary data suggest that concentrate use elicits blood THC levels more than twice as high as cannabis
flower use, and that concentrate use is associated with greater withdrawal, tolerance, and Cannabis Use
Disorder (CUD), prompting concern about the risks of these high potency products in relation to problem use
and CUD. No prior study has evaluated effective treatments to reduce cannabis use in this high risk group.
Several previous studies have found that the non-intoxicating cannabinoid cannabidiol (CBD), which may
antagonize the effects of THC on CB1 and CB2 receptors, reduces cannabis use and CUD-related symptoms,
such as affective disturbance and withdrawal. Results of these studies are promising, but limited to synthetic or
isolated forms of CBD that are not widely available. There have been no tests of the hemp-derived CBD that is
widely available without a prescription across the U.S. Importantly, hemp-derived CBD comes in two forms, one
with a small amount of THC (~0.3% THC, full spectrum; fsCBD) and one without THC (0% THC; broad spectrum;
bsCBD). It is possible that a small amount of THC may confer additional benefits with respect to withdrawal and
related affective disturbance, and in turn be beneficial for reducing THC use overall. Consistent with this
hypothesis, pilot data from our lab suggest that CBD, that also contains low levels of THC, reduces THC drug
reward, withdrawal, anxiety, and overall THC use in heavy concentrate users, supporting the potential for hemp-
derived CBD to reduce THC use and mitigate withdrawal in this high risk group. However, no placebo-controlled
trial has been conducted comparing hemp-derived CBD with and without THC on reducing THC use.
The overarching goal of this proposal is to conduct a placebo-controlled RCT comparing the effects of
hemp-derived CBD (fsCBD vs. bsCBD vs. placebo) on reducing THC use in concentrate users with CUD.
150 adult treatment seeking concentrate users with DSM5 CUD will be recruited to complete an eight-week
protocol. Participants will be randomly assigned to take 400 mg of either hemp-derived bsCBD (contains no
THC), hemp-derived fsCBD (contains low levels of THC), or matched placebo (50 participants per group) daily
for eight weeks. All participants will receive a multi-session empirically supported psychological intervention to
support cannabis use reduction during the trial. Participants will be assessed for changes in THC use [self-
reported mg of THC used and levels of THC’s metabolite 11-nor-9-carboxy-Δ9-THC (THC-COOH)] and CUD
symptoms, as well as levels of CBD and CBD’s metabolite, 7-Carboxy-Cannabidiol (CBD-COOH) to monitor
medication adherence. Primary outcomes include reduction in THC exposure [via self-reported amount used
and...

## Key facts

- **NIH application ID:** 11089903
- **Project number:** 3R01DA059234-02S1
- **Recipient organization:** UNIVERSITY OF COLORADO
- **Principal Investigator:** L. Cinnamon Bidwell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $98,952
- **Award type:** 3
- **Project period:** 2023-09-15 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11089903

## Citation

> US National Institutes of Health, RePORTER application 11089903, Hemp-derived Cannabidiol for the treatment of cannabis use disorder in concentrate users: A double-blind placebo-controlled randomized trial (3R01DA059234-02S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11089903. Licensed CC0.

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