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

Trial Summary

What is the purpose of this trial?

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 and other related outcomes.

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.

How does the drug Intransal opioid differ from other treatments for opioid use disorder?

Intransal opioid, which includes medications like fentanyl, is unique because it is administered through the nose, providing rapid relief from withdrawal symptoms. This method of delivery is different from other common treatments like oral or injectable medications, which may take longer to take effect. ^{1 2 3 4 5}

Research Team

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Re-Purposing FDA-Approved Drugs for Opioid Use Disorder. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Nabiximols as a substitute for cannabis]. [2021]

3. United States 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. [2023]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Is There a Place for Off-Label Pharmacotherapy in Cannabis Use Disorder? A Review on Efficacy and Safety. [2019]

5. United States 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. [2023]