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

NCT ID: NCT03549819

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2024-02-29

Brief Summary

This proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules 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 CBD using biological markers as well as examine the neuro-cognitive effects of CBD treatment.

Detailed Description

The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of flexibly dosed CBD Oil capsules versus 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: CBD Oil Capsules 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: TRIPLE

Study Groups

Cannabidiol (CBD) Oil Capsules

Pure CBD in sunflower lecithin oil, flexibly dosed at 200-800 mg per day

Group Type: EXPERIMENTAL

Cannabidiol (CBD) Oil Capsules

Intervention Type: DRUG

200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose)

Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)

Sunflower Lecithin Oil in Capsule

1-4 capsules daily

Group Type: PLACEBO_COMPARATOR

Sunflower Lecithin Oil in Capsule

Intervention Type: DRUG

Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)

Interventions

Cannabidiol (CBD) Oil Capsules

200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose)

Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)

Intervention Type: DRUG

Sunflower Lecithin Oil in Capsule

Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)

Intervention Type: DRUG

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 of ≥ 22.

2. Physical exam and laboratory findings without clinically significant abnormalities.

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, anti-convulsants, benzodiazepines, stimulants, mood stabilizers)

5. The ability to comprehend and satisfactorily comply with protocol requirements.

6. Written informed consent given prior to entering the baseline period of the study.

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. 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.

6. 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.

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

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

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

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

Sponsors

Tilray

INDUSTRY

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

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Beth Patterson, MSc

Role: primary

bpatter@mcmaster.ca

905-921-7644

Other Identifiers

CBD_ANX

Identifier Type: -

Identifier Source: org_study_id