What side effects are associated with this type of intervention?

Common treatments for substance abuse, particularly those involving cannabinoids like cannabis, dronabinol, and nabilone, are associated with several side effects. These include increased appetite, a sense of well-being, weight gain, slowed thoughts, somnolence (drowsiness), dizziness, and sedation. These side effects can vary in intensity and may impact the overall well-being and daily functioning of patients.

What prior FDA approvals exist?

The FDA has approved several treatments for substance abuse, including varenicline, which is used for smoking cessation and has shown potential for treating cannabis use disorder. Gabapentin, typically used for seizures and neuropathic pain, has also been shown to reduce cannabis use in clinical trials. While cannabinoids like nabiximols (a THC and CBD extract) are approved in some countries for pain management, their role in treating substance abuse is still under investigation. These treatments highlight the potential for using similar pharmacological approaches in managing substance abuse.

What other types of research exist?

Promising novel alternatives to cannabis for substance abuse patients considering treatment in 2024 include new opioid formulations designed to minimize abuse potential, such as abuse-deterrent formulations. Additionally, non-opioid pharmacologic options like selective cannabinoids, muscle relaxants, and botulinum toxin injections for specific pain conditions show potential. Non-pharmacologic therapies, including psychological therapies, yoga, and multidisciplinary pain management models, are also promising for comprehensive pain and substance abuse treatment.

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Opioid Analgesic

Cannabis for Pain Management

Phase 1

Waitlist Available

Led By Caroline A Cooper, PhD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being able to perform all study procedures

Male or non-pregnant female aged 21-53 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Summary

This trial is testing if cannabis can help improve pain relief for patients using a standard pain treatment and whether it increases the risk of misuse. Medical cannabis has been studied for its potential to manage chronic pain, including cancer pain, and has shown some effectiveness in reducing pain and improving quality of life.

Who is the study for?

This trial is for adults aged 21-53 who have used cannabis and opioids before, can do all study tasks, and are not pregnant (women must use birth control). It's not for those with significant illness or certain substance use disorders.

What is being tested?

The study tests how different forms of cannabis affect pain relief and the potential for prescription drug abuse when taken with a low dose of oxycodone. Participants will try THC-only, CBD-only, equal THC:CBD mixtures, or placebo.

What are the potential side effects?

Cannabis may cause dizziness, dry mouth, altered mental state or mood changes. Oxycodone can lead to nausea, constipation, addiction risk and respiratory depression if misused.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can participate in all required study activities.

Select...

I am between 21 and 53 years old and not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cold Pressor Test

Subjective Effects

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: OxycodoneExperimental Treatment2 Interventions

Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)

Group II: Cannabis (THC:CBD = ~1:0) + OxycodoneExperimental Treatment2 Interventions

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

Group III: Cannabis (THC:CBD = ~1:0)Experimental Treatment2 Interventions

Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

Group IV: Cannabis (THC:CBD = ~ 1:1) + OxycodoneExperimental Treatment2 Interventions

Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)

Group V: Cannabis (THC:CBD = ~ 1:1)Experimental Treatment2 Interventions

Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)

Group VI: Cannabis (THC:CBD = ~ 0:1) + OxycodoneExperimental Treatment2 Interventions

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

Group VII: Cannabis (THC:CBD = ~ 0:1)Experimental Treatment2 Interventions

Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

Group VIII: PlaceboPlacebo Group1 Intervention

Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Medical Cannabis

Not yet FDA approved

Medical Cannabis

Not yet FDA approved

Oxycodone

FDA approved

Medical Cannabis

Not yet FDA approved

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for substance abuse include topiramate, which modulates neurotransmitter receptors and ion channels to reduce cravings; varenicline, a nicotinic receptor agonist that diminishes the rewarding effects of substances; NAC, which restores glutamate balance to reduce cravings and withdrawal symptoms; and gabapentin, which stabilizes neural activity to alleviate withdrawal symptoms and reduce substance use. These treatments are crucial for substance abuse patients as they target the neurobiological pathways involved in addiction, helping to manage cravings, withdrawal, and relapse. Understanding these mechanisms is essential for developing effective treatment plans and improving patient outcomes.