DMT + Psychotherapy for Alcoholism

Overseen By Ardavan Mohammad Aghaei

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Disqualifiers: Unstable medical conditions

Compensation: Varies

Number of Visits: 1

Duration: 1 day

63 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the drug DMT combined with psychotherapy for treating alcoholism?

Research on similar treatments, like MDMA-assisted psychotherapy, suggests that combining psychedelics with therapy can help patients explore and address traumatic experiences, which are often linked to alcohol use disorder. Additionally, studies on ketamine-assisted psychotherapy for addiction show promising results, indicating that psychedelic experiences can enhance the effectiveness of psychotherapy in maintaining abstinence. ^{1 2 3 4 5}

Is DMT safe for use in humans?

In a small study, DMT was mostly safe and tolerated in both healthy individuals and those with major depressive disorder, with mild side effects like increased blood pressure and heart rate that resolved quickly. However, more research is needed to confirm these findings. ^{1 6 7 8 9}

How does the drug DMT differ from other treatments for alcoholism?

DMT, the main psychoactive component of ayahuasca, is unique in treating alcoholism because it acts on serotonin 5-HT2A receptors, potentially altering alcohol consumption behavior. Unlike traditional treatments, DMT is a psychedelic that may offer therapeutic effects through profound psychological experiences, which are not typically part of standard alcohol use disorder therapies. ^{2 3 7 10 11}

What is the purpose of this trial?

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

Research Team

Anahita Bassir Nia, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for medically healthy adults who have been diagnosed with Alcohol Use Disorder according to the DSM-5. Participants must be able to give informed consent. People with unstable medical conditions cannot join.

Inclusion Criteria

I am generally in good health.

Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder

Ability to provide consent

Exclusion Criteria

Unstable medical conditions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single psychedelic dose of DMT plus psychotherapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and alcohol consumption over 8 weeks

8 weeks

Weekly visits (in-person or virtual)

Treatment Details

Interventions

• DMT

Trial Overview The study tests the effects of DMT on Alcohol Use Disorder when combined with psychotherapy. It's a double-blind study, meaning neither participants nor researchers know who gets the real treatment or placebo. Some get DMT infusions; others get Diphenhydramine (an antihistamine) and saline as controls.

Participant Groups

Group I: Group 1 Active Control 1 Intervention

Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)

Group II: Group 2 Active Control 1 Intervention

Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)

Group III: Group 3 Placebo Group 1 Intervention

Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a randomized controlled trial involving 122 participants, disulfiram combined with psychotherapy significantly improved treatment retention and increased the duration of abstinence from both alcohol and cocaine.

Cognitive Behavioral Therapy (CBT) and Twelve Step Facilitation (TSF) were more effective in reducing cocaine use compared to supportive psychotherapy, highlighting the importance of combining medication with targeted therapies for individuals with co-occurring substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. Carroll, KM., Nich, C., Ball, SA., et al.[2019]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A scoping review of 77 studies on serotonergic psychedelics (including LSD, ayahuasca, DMT, ibogaine, and mescaline) found that while these substances may improve mood, anxiety, and substance use, the evidence for their safety and efficacy is low-level compared to psilocybin.

Serious adverse events, including homicide and suicide, were reported in studies involving LSD, highlighting potential risks associated with these psychedelic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Psilocybin: Reviewing the Therapeutic Potential of Other Serotonergic Psychedelics in Mental and Substance Use Disorders. Wong, S., Yu, AY., Fabiano, N., et al.[2023]

In a small exploratory phase 1 study involving 10 participants (7 with major depressive disorder and 3 healthy controls), intravenous DMT was found to be mostly safe and well-tolerated, with no dropouts and only mild adverse events reported.

Participants with treatment-resistant major depressive disorder experienced a significant reduction in depression symptoms the day after receiving a 0.3 mg/kg dose of DMT, indicating potential rapid antidepressant effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. D'Souza, DC., Syed, SA., Flynn, LT., et al.[2023]

References

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

Why MDMA therapy for alcohol use disorder? And why now? [2019]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience in using ketamine preparations in the psychotherapy of alcoholism]. [2016]

3. Austria pubmed.ncbi.nlm.nih.gov

[Psychotherapy of alcohol addiction--principles and new findings of therapy research]. [2018]

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

Ketamine psychotherapy for heroin addiction: immediate effects and two-year follow-up. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. [2019]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Role of 5-HT2A receptors in the effects of ayahuasca on ethanol self-administration using a two-bottle choice paradigm in male mice. [2022]

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

Beyond Psilocybin: Reviewing the Therapeutic Potential of Other Serotonergic Psychedelics in Mental and Substance Use Disorders. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The role of psychosocial treatments in pharmacotherapy for alcoholism. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder. [2019]