THC for Cannabis Use Disorder

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic, Bipolar, Psychiatric disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how men and women with cannabis use disorder (CUD) respond to THC, the active ingredient in cannabis. Researchers examine THC's effects on brain activity and reward processing using brain scans. Participants will take either a THC capsule (Dronabinol) or a placebo in different sessions to compare effects. Ideal candidates are adults who use cannabis frequently, such as four or more days a week, and have CUD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking any current psychotropic medications (drugs that affect your mind, emotions, or behavior) to participate in this trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that dronabinol, a synthetic version of THC, has been used safely in numerous studies. It aids individuals trying to quit cannabis by reducing withdrawal symptoms, easing the challenging side effects.

Some studies have found that dronabinol is generally well-tolerated. However, high doses might cause mood changes or feelings of anxiety, particularly if not used properly. In a clinical trial, where conditions are carefully controlled, the risk of such effects is lower. Additionally, the FDA has approved dronabinol for other uses, indicating its well-established safety.

Overall, dronabinol has been extensively studied and is generally safe when used as directed. Participants in clinical trials receive close monitoring, providing an extra layer of safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cannabis use disorder?

Dronabinol is unique because it uses a synthetic form of THC, the active ingredient in cannabis, to address cannabis use disorder. Unlike other treatments that often focus on behavioral therapy or abstinence, dronabinol targets the biological pathways involved in addiction by mimicking the effects of cannabis without the harmful components of smoking. Researchers are excited because this approach could help reduce withdrawal symptoms and cravings, offering a new avenue for those struggling to quit cannabis.

What evidence suggests that Dronabinol might be an effective treatment for cannabis use disorder?

In this trial, participants will receive either dronabinol, a man-made version of THC, or a placebo. Research has shown that dronabinol can help individuals with cannabis use disorder (CUD) reduce their self-reported cannabis use. Some studies found that it alleviates withdrawal symptoms like restlessness and upset stomach, making it easier for individuals to adhere to their treatment plans. However, dronabinol alone did not significantly reduce the likelihood of returning to cannabis use compared to a placebo. While it appears helpful for easing withdrawal and maintaining treatment adherence, the overall evidence for its effectiveness in reducing cannabis use remains mixed. ^{1 6 7 8 9}

Who Is on the Research Team?

Erin Martin, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with Cannabis Use Disorder (CUD). Participants must be able to undergo MRI scans and take oral medication. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline health conditions, substance use behaviors, and other factors relevant to the study.

Inclusion Criteria

I am between 21 and 45 years old.

THC-positive urine

BMI 18-30

Exclusion Criteria

Treatment-seeking for Substance Use Disorder (SUD)

Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)

Pregnancy/nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosing Sessions

Participants complete two counterbalanced dosing sessions with oral THC 40 mg vs. placebo

1-2 weeks

2 visits (in-person)

Neuroimaging and Assessment

Neuroimaging (MRS and fMRI) to assess glutamate levels and BOLD response, along with subjective drug effect assessments

0-7 hours post-dose

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after dosing sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol
• Placebo

Trial Overview The study is examining how THC affects reward processing in men and women differently. It uses brain imaging techniques to measure changes after taking either a placebo or Dronabinol (synthetic THC), which participants will receive on two separate occasions.

How Is the Trial Designed?

Group I: Males Experimental Treatment 2 Interventions

Group II: Females Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9256935/

Cannabinoids in the Treatment of Cannabis Use Disorder Dronabinol: Dronabinol reduced self-reported cannabis use during an overall 12-week treatment phase compared to baseline. However, there were no ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0149763421005273

Cannabinoids for the treatment of cannabis use disorder Dronabinol decreased some withdrawal symptoms but did not decrease relapse to cannabis use compared to placebo.Combined dronabinol and lofexidine decreased ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3154755/

Dronabinol for the Treatment of Cannabis Dependence Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms.

4. link.springer.com link.springer.com/article/10.1007/s40265-024-02098-1

Exploring Novel Pharmacotherapy Candidates for ... Dronabinol with lofexidine decreased symptoms such as restlessness, chills, upset stomach, and cannabis craving. Results support combining ...

5. cannabisevidence.org cannabisevidence.org/wp-content/uploads/2022/01/Rx_forCUD_12-2022v2_FINAL.pdf

Pharmacotherapy for the Treatment of Cannabis Use ... Across the 28 included studies, we found very low– to low-certainty evidence for all the GRADE outcomes we assessed, due to small sample sizes and small numbers ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf

marinol - accessdata.fda.gov Ingestion of high doses of dronabinol increases the risk of psychiatric adverse reactions if abused or misused, while continued administration can lead to ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.867878/full

Cannabinoids in the Treatment of Cannabis Use Disorder As expected, dronabinol attenuated cannabis withdrawal symptoms and improved retention in treatment but failed to reduce cannabis use and to ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2338251

Cannabinoids for Medical Use: A Systematic Review and ... There was low-quality evidence suggesting that cannabinoids were associated with improvements in nausea and vomiting due to chemotherapy, weight gain in HIV ...

9. pharmacy.hsc.wvu.edu pharmacy.hsc.wvu.edu/media/1172/dronabinol-for-cannabis-dependence.pdf

Dronabinol for the Treatment of Cannabis Dependence CONCLUSIONS: Dronabinol for the treatment of cannabis dependence shows promise. Although this study didn't prove much statistical significance, success may be ...