What side effects are associated with this type of intervention?

Common treatments for substance abuse, particularly those involving cannabinoid agonists like dronabinol, nabilone, and nabiximols, often have side effects such as somnolence, dizziness, impaired concentration, confusion, and mood changes. These treatments can also lead to higher dropout rates due to adverse effects. Additionally, gabapentin, used for reducing cannabis use, may cause headaches, insomnia, and mood changes. It is important to monitor for respiratory depression when gabapentin is used with other central nervous system depressants.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of substance abuse that interact with the endocannabinoid system or similar pathways. Nabiximols, a cannabis whole-plant extract containing a 1:1 ratio of THC and cannabidiol, is approved for treating multiple sclerosis-related spasticity and has shown promise in managing chronic pain. Additionally, gabapentin, a GABAergic agent, has been used off-label to reduce cannabis use and alleviate withdrawal symptoms in individuals with cannabis use disorder. These treatments highlight the potential of targeting the endocannabinoid system and related pathways for managing substance abuse and associated pain.

What other types of research exist?

Promising alternatives to cannabis for substance abuse patients include gabapentin, NAC (N-acetylcysteine), and the cannabinoid CB2 receptor agonist LY2828360. These treatments have shown potential in reducing substance use and withdrawal symptoms while modulating pain and reward pathways.

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Cannabis for Pain Relief (CanSex Trial)

Phase 1

Recruiting

Led By Ziva Cooper, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

FEMALES: Must be regularly cycling

Male or non-pregnant female aged 21-55 years

Must not have

FEMALES: using a hormonal contraceptive

Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 hours

Summary

This trial is studying the effects of smoking cannabis on pain relief and potential abuse in men and women. Researchers are comparing how different doses affect each sex and how their bodies process THC, the active ingredient in cannabis. The goal is to understand if there are significant differences between men and women in these effects.

Who is the study for?

This trial is for men and women aged 21-55 who use cannabis weekly but aren't seeking treatment for it. Women must have regular cycles and use non-hormonal birth control. Participants should be healthy, with a BMI of 18.5 - 34kg/m2, and able to do all study tasks.

What is being tested?

The CanSex study is testing the effects of actual cannabis versus placebo on pain relief and potential abuse in both men and women to understand if there are sex differences in these responses.

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any adverse reactions due to smoking cannabis which could include changes in mood, sensory perception, alertness, or coordination.

Eligibility Criteria

Inclusion Criteria

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

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I have regular menstrual cycles.

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I am between 21 and 55 years old and not pregnant.

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I am using a non-hormonal method of birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using hormonal birth control.

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I am currently using medical cannabis, painkillers, or other medications that could influence the study.

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I am currently experiencing pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Analgesia as measured using the Cold Pressor Test

Pharmacokinetics of THC and metabolites

Subject-rated drug effects

Secondary study objectives

Drug reinforcement using the cannabis self-administration task

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low strength cannabisExperimental Treatment1 Intervention

Smoked Cannabis (\~4% THC)

Group II: Higher strength cannabisExperimental Treatment1 Intervention

Smoked Cannabis (\~10% THC)

Group III: PlaceboPlacebo Group1 Intervention

Smoked Cannabis (\~0% THC)

0 / 6Eligibility 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 often target the endocannabinoid system, which is involved in pain modulation and reward pathways. Cannabinoid-based therapies like nabiximols aim to modulate this system to alleviate withdrawal symptoms and cravings. Other medications, such as gabapentin and varenicline, work by stabilizing neurotransmitter systems to manage withdrawal and reduce cravings. These mechanisms are crucial for substance abuse patients as they help in selecting treatments that specifically address the disrupted pathways in addiction, thereby enhancing the likelihood of successful recovery.

Using Ecological Momentary Assessment to Identify Mechanisms of Change: An Application From a Pharmacotherapy Trial With Adolescent Cannabis Users.