Cannabis for Opioid Use Disorder

Overseen By Paul Nuzzo, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Kentucky

Disqualifiers: Medical conditions requiring management

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cannabis might help individuals with opioid use disorder manage withdrawal symptoms. Participants will receive either vaporized cannabis or a placebo and an experimental dose of an intranasal opioid. The goal is to determine if cannabis can ease withdrawal and improve related outcomes. Ideal candidates are those currently dealing with opioid use disorder who are not seeking other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it excludes those with medical conditions that require ongoing medical management.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using vaporized cannabis is generally safe. In one study, participants reported no serious side effects. About 15.4% experienced mild effects like dry mouth or feeling slightly high. Another study found that inhaling cannabis did not harm the lungs and posed fewer risks of negative reactions.

Specific safety data for the intranasal opioid agonist in this study isn't available yet. As this trial is in its early phase, researchers are primarily assessing its safety for humans. This careful approach is a normal part of testing new treatments. If the treatment had been approved for other uses, it might suggest some level of safety, but that's not the case here. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for opioid use disorder because they explore alternative ways to help people reduce or quit opioid use. Unlike standard treatments like methadone or buprenorphine, which primarily target opioid receptors, vaporized cannabis might offer a new approach by potentially easing withdrawal symptoms and reducing cravings through different pathways in the brain. Meanwhile, the intranasal opioid agonist provides a novel delivery method, which could allow for rapid absorption and more immediate effects, offering a different approach to managing opioid dependence. This trial could pave the way for innovative, complementary strategies to existing therapies, offering new hope for those struggling with opioid addiction.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that cannabis, particularly strains high in CBD (cannabidiol), might aid individuals with opioid addiction by reducing cravings and preventing relapse. In this trial, one group of participants will receive vaporized cannabis to assess its effects on opioid use disorder. Specifically, one study found that CBD can make opioids less appealing, potentially aiding in cessation. Another study suggested that using cannabis before taking opioids can lessen withdrawal symptoms, though further research is needed to confirm this. Overall, vaporized cannabis may help ease withdrawal and reduce the risk of returning to opioid use. ^{6 7 8 9 10}

Who Is on the Research Team?

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder who are not currently seeking treatment. Participants must be diagnosed with an opioid use disorder to qualify.

Inclusion Criteria

You currently have an opioid use disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-therapeutic, experimental doses of an opioid agonist or placebo and vaporized cannabis or placebo

6-8 weeks

Multiple sessions with administration of substances

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled vaporized cannabis
• Intransal opioid

Trial Overview The study is testing the effects of inhaled vaporized cannabis compared to intranasal opioids on withdrawal symptoms and other outcomes related to opioid use disorder.

How Is the Trial Designed?

Group I: Vaporized cannabis Experimental Treatment 2 Interventions

Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.

Group II: Intranasal Opioid Agonist Experimental Treatment 2 Interventions

Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).

Intransal opioid is already approved in United States, European Union for the following indications:

Approved in United States as Fentanyl for:

• Severe pain in cancer patients
• Breakthrough cancer pain
• Chronic pain in opioid-tolerant patients

Approved in European Union as Fentanyl for:

• Severe chronic pain in adults
• Breakthrough pain in cancer patients

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

From 2010 to 2014, the prevalence of opioid use disorder (OUD) diagnoses increased fourfold among commercially insured individuals, yet the proportion of those receiving medication for OUD decreased significantly from 25% to 16%.

Discontinuation rates for OUD medications were notably high, with over 50% of patients discontinuing injectable and oral naltrexone within 30 days, indicating a need for improved strategies to maintain treatment adherence, especially compared to sublingual buprenorphine/naloxone, which had lower discontinuation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. Morgan, JR., Schackman, BR., Leff, JA., et al.[2023]

The study identified 8 FDA-approved medications, including prazosin and bupropion, that may promote remission in individuals with opioid use disorder (OUD) without the use of standard treatments like buprenorphine or methadone.

Additionally, certain psychiatric medications, when used alongside buprenorphine or methadone, were found to improve remission rates, suggesting a potential for integrated treatment approaches for OUD and comorbid mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-Purposing FDA-Approved Drugs for Opioid Use Disorder. Patel, K., Waldron, D., Graziane, N.[2023]

In a study of 1389 participants undergoing methadone maintenance treatment (MMT), lower daily doses of methadone (<90 mg/day) significantly increased the likelihood of daily illicit opioid use, especially when cannabis use was low or absent.

The findings suggest that daily cannabis use may reduce the risk of illicit opioid use associated with low methadone doses, indicating a potential role for cannabis as an adjunct treatment in MMT, warranting further clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cannabis-Dependent Relationship Between Methadone Treatment Dose and Illicit Opioid Use in a Community-Based Cohort of People Who Use Drugs. Lake, S., Kerr, T., Buxton, J., et al.[2023]

A systematic review of 43 articles identified only 4 positive results from 13 double-blind, randomized placebo-controlled trials testing drugs for cannabis use disorder (CUD), indicating limited efficacy for off-label treatments.

While N-acetylcysteine shows an acceptable benefit-risk balance for treating CUD, the safety and efficacy of gabapentin, dronabinol, and nabiximols remain uncertain, suggesting these should not be routinely prescribed without further evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Place for Off-Label Pharmacotherapy in Cannabis Use Disorder? A Review on Efficacy and Safety. Laprevote, V., Schwan, R., Schwitzer, T., et al.[2019]

In a 12-week study, patients treated with nabiximols spray (containing THC and CBD) significantly reduced their cannabis use by an average of 18.6 days compared to those on a placebo.

Despite the reduction in cannabis use, there were no significant differences between the nabiximols and placebo groups in terms of overall health, cravings, withdrawal symptoms, or achieving complete abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nabiximols as a substitute for cannabis]. Dumont, GJH.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05729932

NCT05729932 | Cannabis and Opioid Use Disorder This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10019487/

High-CBD Cannabis Vapor Attenuates Opioid Reward and ... Combined, these results suggest that CBD may have great therapeutic potential in opioid use disorder by reducing drug craving and relapse. Our previous ...

3. psycnet.apa.org psycnet.apa.org/doiLanding?doi=10.1037%2Fpha0000796

The effects of vaped cannabis on the severity of naloxone ... By using a V-CB pretreatment, we may have inflated cannabis's utility in suppressing opioid withdrawal. Future studies should employ a more ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/11/1/e040349

Association between vaping and health outcomes in ... The primary objective of this review is to systematically assess the literature related to patients with OUD and the effects vaping has shown on their physical ...

5. withpower.com withpower.com/trial/phase-1-opioid-related-disorders-3-2023-d91ec

Cannabis for Opioid Use Disorder In a 12-week study, patients treated with nabiximols spray (containing THC and CBD) significantly reduced their cannabis use by an average of 18.6 days compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569620/

Cannabis as a Substitute for Opioid-Based Pain Medication Cannabis can be an effective treatment for pain, greatly reduces the chance of dependence, and eliminates the risk of fatal overdose compared to opioid-based ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772392522000451

High-CBD Cannabis Vapor Attenuates Opioid Reward and ... Inhaled high-CBD whole-plant cannabis extract (WPE) has mild anti-allodynic effects in female rats. WPE significantly reduces opioid reward in females.

8. mdpi.com mdpi.com/2227-9059/13/10/2406

Long-Term Efficacy and Safety of Inhaled Cannabis ... No serious adverse events were reported; mild side effects (e.g., dry mouth or euphoria) occurred in 15.4% of patients. Conclusions: Inhaled cannabis showed ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05729932

NCT05729932 | Cannabis and Opioid Use Disorder This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal ...

10. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/can.2023.0219

Clinical Application of Cannabis Vaporization To date, there is favorable safety data showing no respiratory effects and a lower risk of adverse events. Another advantage is that some devices record the ...