Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study

NCT ID: NCT04569760

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-06-30

Brief Summary

This proposed study aims to evaluate the efficacy of a daily oral cannabinoid oil preparation in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and cannabinoids using biological markers as well as examine the neuro-cognitive effects of cannabinoid treatment.

Detailed Description

The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of a flexibly dosed cannabinoid oil preparation versus matching placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: cannabinoid oil preparation or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders.

To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete.

If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory.

Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.

Conditions

Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabinoid Oil - Oral Preparation

50mg CBD: 2mg of THC in each 1ml drop in MCT Oil, flexibly dosed at 200-800 mg per day.

Dosing will start at 2 mls twice a day for one week and be titrated to 4 mls twice/daily for one week. At the end of Week 2, dose may be titrated to 6 mls twice a day ; then at the end of Week 4, dose may be titrated to 8 mls twice daily (the maximum of 800 mg/day total dose of High CBD).

The dose will be titrated in increments of 200 mg (4 mls)/day/week if participants are tolerating their current dose, are experiencing no adverse events and have not fully responded so that they may potentially reach 800 mg/day/week by Week 4.

Group Type: EXPERIMENTAL

50:2 mg(CBD:THC)/ml - Cannabinoid Oil Oral Preparation- titrated as tolerated up to a maximum 8mls twice daily (200 mg- 800 mg total dose)

Intervention Type: DRUG

Oral cannabinoid oil preparation dosed in 1ml increments

Placebo Oil - Oral Preparation

MCT Oil

Dosing will start at 2 mls twice a day for one week and be titrated to 4 mls twice/daily for one week. At the end of Week 2, dose may be titrated to 6 mls twice a day ; then at the end of Week 4, dose may be titrated to 8 mls twice daily (a volume equivalent to the maximum of 800 mg/day total dose of High CBD).

The dose will be titrated in incremental volumes equivalent to 200 mg of active product (4 mls)/day/week if participants are tolerating their current dose, are experiencing no adverse events and have not fully responded so that they may potentially reach the volume equivalent to 800 mg/day/week by Week 4.

Group Type: PLACEBO_COMPARATOR

Placebo Oil

Intervention Type: DRUG

Oral MCT Oil Preparation - No cannabinoids- titrated as tolerated up to a maximum of 8mls twice daily (equivalent to 200 mg- 800 mg total dose of the active product)

Interventions

50:2 mg(CBD:THC)/ml - Cannabinoid Oil Oral Preparation- titrated as tolerated up to a maximum 8mls twice daily (200 mg- 800 mg total dose)

Oral cannabinoid oil preparation dosed in 1ml increments

Intervention Type: DRUG

Placebo Oil

Oral MCT Oil Preparation - No cannabinoids- titrated as tolerated up to a maximum of 8mls twice daily (equivalent to 200 mg- 800 mg total dose of the active product)

Intervention Type: DRUG

Other Intervention Names

Active; Placebo

Eligibility Criteria

Inclusion Criteria

1. Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis of either GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score greater than or equal to 22.

2. Physical exam and laboratory findings without clinically significant abnormalities. Screening bloodwork values for hematology and chemistry are to be Within Normal Limits.

3. Participants must agree to abstain from recreational cannabis use for the duration of the study.

4. Concomitant psychotropic medication use will be allowed provided that the dose has been stable for 8 weeks prior to randomization. (including antidepressants, anti-psychotics, benzodiazepines, and stimulants)

Exclusion Criteria

1. Current recreational or medicinal use of cannabis within 4 weeks of study initiation.

2. Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder) will be excluded.

3. Participants with a lifetime history of daily cannabis use will be excluded.

4. Dose changes of concomitant medication will not be permitted during the study period.

5. Participants currently using medications that are CYP3A4, CYP2C19 or CYP2D6 inhibitors or inducers which includes but is not limited to: tricyclic antidepressants, topiramate, clobazam, amitriptyline, fentanyl, the related opioids sufentanil and alfentanil, codeine, oxycodone, macrolides, calcium channel blockers, cyclosporine, sildenafil, tadalafil, antihistamines, antiretrovirals, atorvastatin and simvastatin, warfarin and valproate or other anti-epileptics.

6. Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.

7. Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorders, bipolar disorder. Entry of patients with obsessive compulsive disorder or posttraumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.

8. Major depression will be allowed if not severe (Montgomery Asberg Depression Rating Scale-MADRS28≥ 25). Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.

9. Participants with a family history of psychosis will be excluded.

10. Participants who have a history of adverse reactions to cannabis will be excluded.

11. Participants who have severe cardiovascular, immunological, liver, or kidney disease, arrhythmia or a history of arrhythmias will be excluded.

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• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediPharm Labs Corp

UNKNOWN

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Van Ameringen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

MacAnxiety Research Centre

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

CBD_ANX_2

Identifier Type: -

Identifier Source: org_study_id