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Cannabidiol as a Treatment for AUD Comorbid With PTSD
Phase 1, PHASE2 trial testing Cannabidiol in Alcohol Use Disorder in 95 participants. Completed in 20 April 2022.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 95 |
| Start date | 16 September 2019 |
| Primary completion | 20 April 2022 |
| Estimated completion | 20 April 2022 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
Adults 18 to 70, any sex, with Alcohol Use Disorder or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 4.4885 | ± 2.6620 |
| Placebo | 5.3623 | ± 2.7075 |
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 1.9256 | ± 2.1786 |
| Placebo | 2.15 | ± 2.2792 |
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 2.4881 | ± 2.1679 |
| Placebo | 2.8175 | ± 2.2682 |
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 42.0588 | ± 13.8549 |
| Placebo | 49.1538 | ± 13.7739 |
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 19.9231 | ± 15.7116 |
| Placebo | 29.9 | ± 16.7559 |
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 26.6364 | ± 18.4921 |
| Placebo | 26.8889 | ± 17.7331 |
CDT test performed on blood sample
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 1.1118 | 0.6 – 2.6 |
| Placebo | 2.2833 | 0.5 – 8.8 |
CDT test performed on blood sample
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 1.0909 | 0.6 – 2.1 |
| Placebo | 1.4222 | 0.6 – 3.4 |
CDT test performed on blood sample
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 1.14 | 0.7 – 1.9 |
| Placebo | 1.6625 | 0.6 – 5.8 |
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 49 | 17 – 97 |
| Placebo | 58 | 13 – 100 |
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 29 | 0 – 100 |
| Placebo | 31 | 0 – 100 |
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
| Group | Value | 95% CI |
|---|---|---|
| Cannabidiol (CBD 600 mg Daily) | 25 | 0 – 100 |
| Placebo | 31 | 0 – 100 |
Time frame: 9 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cannabidiol (CBD 600 mg Da… | Placebo |
|---|---|---|---|
| Drowsiness | General disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Weight gain | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Headache | Gastrointestinal disorders | — | — |
| Increased Hunger | General disorders | — | — |
| Nightmares | General disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Lightheadedness/Dizziness | General disorders | — | — |
| Thyroid Nodule | Endocrine disorders | — | — |
| Acid Reflux | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Blurry Vision | Eye disorders | — | — |
| Cold/Flu Symptoms | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Elevated liver enzymes | General disorders | — | — |
| Feeling Overwhelmed | Psychiatric disorders | — | — |
| Fever | General disorders | — | — |
| Hypotension | Cardiac disorders | — | — |
| Insomnia | General disorders | — | — |
| Irregular heartbeat | Cardiac disorders | — | — |
| Lack of motivation | Psychiatric disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Perceptual problems | General disorders | — | — |
| Arm surgery | Musculoskeletal and connective tissue disorders | — | — |
| Feeling hot | General disorders | — | — |
| Shortness of breath | Vascular disorders | — | — |
| Stomach discomfort | Gastrointestinal disorders | — | — |
| Suicidal ideation (wish to be dead) | Psychiatric disorders | — | — |
| Sweating | General disorders | — | — |
Data from ClinicalTrials.gov NCT03248167 adverse events section.
This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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