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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether DMT, a psychedelic substance, combined with psychotherapy, can help people with Alcohol Use Disorder. Researchers are testing two different doses of DMT to determine if it reduces alcohol cravings and supports recovery. A placebo group receives a standard allergy medicine for comparison. The trial seeks participants diagnosed with Alcohol Use Disorder who are otherwise medically healthy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DMT, the treatment under study, is generally safe for humans. However, users often report intense experiences or "trips" that can be very strong and sometimes overwhelming.

Studies have not identified serious long-term harmful effects from DMT itself, but the immediate effects can vary based on the dosage. In controlled settings, researchers closely monitor participants to manage any unexpected reactions.

Since this study is in the early stages, it primarily focuses on assessing the safety of DMT and participants' ability to tolerate it. Researchers are still gathering detailed safety information.

People with a history of drug or alcohol abuse in the past year are typically excluded from these studies to reduce risks, highlighting the emphasis on safety in these trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike the standard treatments for alcoholism, which often include medications like disulfiram, naltrexone, or acamprosate that focus on reducing cravings or causing adverse reactions to alcohol, this new approach uses DMT (dimethyltryptamine) combined with psychotherapy. DMT is unique because it potentially alters brain chemistry by interacting with serotonin receptors, which could lead to profound psychological insights and behavioral changes. Researchers are excited about this treatment because it could offer rapid therapeutic effects and potentially address underlying psychological issues more effectively than traditional methods. By integrating DMT with psychotherapy, this approach aims to provide a deeper, more holistic treatment experience that could transform how alcoholism is managed.

What evidence suggests that DMT plus psychotherapy might be an effective treatment for Alcohol Use Disorder?

Research has shown that DMT, one of the treatments in this trial, might help reduce alcohol use when combined with therapy. A large survey found that experiences with 5-MeO-DMT, a compound similar to DMT, were linked to improvements in alcoholism. Another study found that DMT lowered the desire for alcohol when participants encountered alcohol-related triggers. These findings suggest that DMT could help reduce alcohol cravings and possibly lower alcohol consumption. While more research is needed, early evidence supports DMT's potential as a treatment for Alcohol Use Disorder. Participants in this trial will receive different dosages of DMT or a placebo to evaluate its effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Anahita Bassir Nia, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06070649

Study Details | NCT06070649 | The Potential Therapeutic ...

The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11007263/

The potential of 5‐methoxy‐N,N‐dimethyltryptamine in ...

Consistently, one large survey study demonstrated that the 5‐MeO‐DMT‐induced mystical experience is associated with improvements in alcoholism ...

3.

isrctn.com

isrctn.com/ISRCTN13970288

the effects of dimethyltryptamine (DMT) on drinking

DMT will reduce cue reactivity (liking/wanting) to alcohol stimuli compared to placebo, with the greatest reductions when DMT is combined with ...

4.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2795625

Percentage of Heavy Drinking Days Following Psilocybin ...

The results in this trial showed that psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking ...

5.

medicine.yale.edu

medicine.yale.edu/news-article/four-yale-psychiatry-researchers-awarded-grants-to-study-alcohol-use-disorder/

Four Yale Psychiatry Researchers Awarded Grants to Study ...

The study is titled, "The Effects of N, N-dimethyltryptamine (DMT) on Neuroplasticity in Individuals With Alcohol Use Disorder (AUD)." The ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12070030/

Safety, Pharmacokinetics, and Pharmacodynamics of a 6‐h N ...

To optimize safety, participants with a history of drug or alcohol abuse within the past year, a personal or first‐degree family history of ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1111/adb.13386

The potential of 5‐methoxy‐N,N‐dimethyltryptamine in ...

Alcohol use disorder (AUD) can be defined as a pattern of compulsive heavy alcohol use and a loss of control over alcohol intake despite adverse ...

8.

dl.novachem.com.au

dl.novachem.com.au/sds/assets/novachem.sds.D-102.pdf

N,N-Dimethyltryptamine (DMT) - Novachem

The SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards ...