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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA030649-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
This study is a placebo-controlled, randomized, double blind, clinical trial to investigate the safety, tolerability and efficacy of the psychedelic dimethyltryptamine (DMT), in addition to a short course of psychotherapy, on Alcohol Use Disorder (AUD). The investigators hypothesize that relative to control (0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion plus psychotherapy), a single psychedelic dose of DMT (plus psychotherapy) in individuals with AUD will 1) be safe and 2) well-tolerated, and 3) reduce alcohol consumption measured in the laboratory the day after, and over the following 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min) |
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| Group 2 | Active Comparator | Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min) |
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| Group 3 | Placebo Comparator | Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion | Drug | Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of DMT in women and men with AUD | Systematic Assessment for Treatment Emergent Effects (SAFTEE) and MedDRA will be used weekly for 8 weeks to assess safety and tolerability of DMT in women and men with AUD. | Day 0 through Day 56 |
| The effects of DMT, plus psychotherapy, on alcohol consumption | We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm. | Day 0 through Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between acute psychedelic effects of DMT and alcohol consumption | The Mystical Experience Questionnaire (MEQ) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption. | Day 0 through Day 56 |
| The relationship between acute psychedelic effects of DMT and alcohol consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelina Contreras | Contact | (203) 974-7525 | angelina.contreras@yale.edu | |
| Ardavan Mohammad Aghaei | Contact | ardavan.mohammadaghaei@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anahita Bassir Nia, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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| 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion | Drug | Infusion |
|
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| 25 mg Diphenhydramine (5 min) + Normal Saline | Drug | Infusion |
|
The Ego-Dissolution Inventory (EDI) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption. |
| Day 0 through Day 56 |
| The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. | The Timeline Followback (TLFB) approach will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption. | Day 0 through Day 56 |
| The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. | Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption. | Day 0 through Day 56 |
| The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. | Substance use disorder behaviors and risks with the Brief Addiction Monitor (BAM) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption. | Day 0 through Day 56 |
| The prosocial effects of DMT, plus psychotherapy, and changes in personality traits | Prosocial effects with be assessed using the Prosocial Personality Battery (PSP). The scale consists of 56 total items and uses a Likert-type scale with 5 answer-choices. | Day 0 through Day 56 |
| The prosocial effects of DMT, plus psychotherapy, and changes in personality traits | Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R). | Day 0 through Day 56 |
| The prosocial effects of DMT, plus psychotherapy, and changes in personality traits | Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS). | Day 0 through Day 56 |
| The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma | The Life Events Checklist (LEC) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma. | Day 0 through Day 56 |
| The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma | The Childhood Trauma Questionnaire (CTQ-SF) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma. | Day 0 through Day 56 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004130 | N,N-Dimethyltryptamine |
| D004155 | Diphenhydramine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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