Dronabinol for HIV/AIDS

Overseen By Brooklyn A Bradley, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Yale University

Must be taking: Antiretroviral therapy

Must not be taking: CNS depressants, Anticholinergics

Disqualifiers: Psychosis, Cardiac disorders, Seizures, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to define the mechanisms of cannabis on the genome of people with HIV who use cannabis. The investigator aims to better understand the effect of Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status dependent. This research may better inform public health policy regarding cannabis use. Depending on the results, additional studies may also build upon this research to develop more effective and specific treatments for cannabis use associated disorders.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using drugs that cause dizziness, confusion, or sedation, or if you have certain medical conditions. It's best to discuss your specific medications with the trial team.

Is dronabinol generally safe for humans?

Dronabinol is generally considered safe for humans, with common side effects including dry mouth, dizziness, and headache, which are usually mild to moderate and temporary. Serious side effects can include confusion, anxiety, and hallucinations, but these are less common. ^{1 2 3 4 5}

How does the drug dronabinol differ from other treatments for HIV/AIDS?

Dronabinol is unique because it is an oral form of delta-9-tetrahydrocannabinol (THC), the active component of cannabis, and is used to stimulate appetite and manage weight loss in HIV/AIDS patients. Unlike other treatments, it is specifically approved for HIV-related anorexia and has shown to improve appetite and cause weight gain in patients, which is crucial for managing wasting syndrome associated with the condition. ^{1 3 4 6 7}

Research Team

Ke Xu, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults with HIV/AIDS who currently use or have used cannabis, are on antiretroviral therapy, and have a low viral load. They must be in good health overall and women able to bear children should agree to use birth control during the study.

Inclusion Criteria

Meet criteria of viral suppression (viral load less than approximately 400 copies/ml).

Current or past Cannabis use.

Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Dronabinol and undergo transcriptome and chromatin structure profiling

Baseline, 120 minutes, and 360 minutes post-Dronabinol

3 visits (in-person)

Follow-up

Participants are monitored for long-term changes in gene networks and immune response

up to 5 years

Treatment Details

Interventions

• Dronabinol (Cannabinoid)

Trial Overview The study tests Dronabinol Capsules to understand their effects on immune function and inflammation in people with HIV who consume cannabis. It will explore if these effects depend on one's HIV status, potentially guiding future treatments.

Participant Groups

Group I: People without HIV (PWoH) with Cannabis use Experimental Treatment 1 Intervention

PWoH with Cannabis use

Group II: People with HIV (PWH) with Cannabis use Experimental Treatment 1 Intervention

PWH with cannabis use

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study involving 7 HIV-positive marijuana smokers, high doses of dronabinol (10 mg QID) were found to safely increase caloric intake and improve sleep quality, but only during the first 8 days of treatment.

Participants experienced sustained mood enhancement over the 16-day study, indicating that while dronabinol is effective, there may be a need for higher doses to maintain its appetite-stimulating effects due to the development of tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of high-dose dronabinol maintenance in HIV-positive marijuana smokers: a controlled laboratory study. Bedi, G., Foltin, RW., Gunderson, EW., et al.[2022]

In a study of 52 patients with HIV wasting syndrome, megestrol acetate significantly increased weight over 12 weeks, with the highest gain seen in those taking 750 mg/day, while dronabinol alone led to weight loss.

Both drugs were generally safe, with no significant differences in adverse events among treatment groups, although dronabinol was associated with central nervous system side effects, and megestrol acetate was linked to changes in liver enzymes and hyperglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. Timpone, JG., Wright, DJ., Li, N., et al.[2013]

In a study involving 30 HIV-positive marijuana smokers, both smoked marijuana and lower doses of dronabinol (10 and 20 mg) were well tolerated and significantly increased caloric intake, particularly in those with muscle mass loss.

The highest dose of dronabinol (30 mg) was poorly tolerated by some participants, indicating that while both treatments can enhance food intake, careful dosing is important for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. Haney, M., Rabkin, J., Gunderson, E., et al.[2022]

Chronic administration of Δ(9)-THC did not significantly affect the progression of SIV infection in male Chinese-derived rhesus macaques, as there were no notable differences in viral loads compared to the placebo group.

Long-term Δ(9)-THC treatment was associated with a significant reduction in circulating IgE(+)B cells, suggesting potential immunomodulatory effects, but it did not enhance the pathogenicity of the SIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Δ(9)-Tetrahydrocannabinol Administration Reduces IgE(+)B Cells but Unlikely Enhances Pathogenic SIVmac251 Infection in Male Rhesus Macaques of Chinese Origin. Wei, Q., Liu, L., Cong, Z., et al.[2018]

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.

Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]

In a study involving 10 experienced marijuana smokers, oral Delta-9-tetrahydrocannabinol (Delta(9)-THC) was found to be chosen more often than a placebo, indicating some reinforcing effects, although participants selected it less than 50% of the time.

Both doses of Delta(9)-THC (10 mg and 20 mg) led to significant increases in positive subjective effects, impaired psychomotor performance, and increased heart rate, suggesting potential safety concerns alongside its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinforcing effects of oral Delta9-THC in male marijuana smokers in a laboratory choice procedure. Hart, CL., Haney, M., Vosburg, SK., et al.[2022]

Dronabinol, a form of THC, has been effective in reducing nausea and vomiting in cancer patients undergoing chemotherapy, especially when used alongside prochlorperazine, which also helps reduce the psychotropic effects of dronabinol.

In patients with symptomatic HIV infection, dronabinol not only improved appetite but also led to weight gain in 70% of the participants, indicating its potential benefits for appetite stimulation in chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent clinical experience with dronabinol. Plasse, TF., Gorter, RW., Krasnow, SH., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of high-dose dronabinol maintenance in HIV-positive marijuana smokers: a controlled laboratory study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Chronic Δ(9)-Tetrahydrocannabinol Administration Reduces IgE(+)B Cells but Unlikely Enhances Pathogenic SIVmac251 Infection in Male Rhesus Macaques of Chinese Origin. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Reinforcing effects of oral Delta9-THC in male marijuana smokers in a laboratory choice procedure. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Recent clinical experience with dronabinol. [2019]