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

NCT03549819 | Unknown Phase 3

• 1 other identifier: CBD_ANX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anxiety Disorders; Cannabidiol; Cannabis

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  The 14-item HAM-A was developed to assess general anxiety symptoms in a clinical population and has proven sensitive to change with treatment. It is a clinician-rated measure and will be administered at each visit by a trained, blinded rater, using the Structured Interview Guide for the HAM-A. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) are summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.

  Change from baseline to week 8

Secondary Outcomes (27)

• Clinical Global Impression - Severity (CGI-S)

  Change from baseline to week 8

• Clinical Global Impression - Improvement (CGI-I)

  Change from baseline to week 8

• Generalized Anxiety Disorder-7 (GAD-7)

  Change from baseline to week 8

• Liebowitz Social Anxiety Scale- Self Report (LSAS-SR)

  Change from baseline to week 8

• Panic and Agoraphobia Scale (PAS)

  Change from baseline to week 8

Study Arms (2)

Cannabidiol (CBD) Oil Capsules

EXPERIMENTAL

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

Drug: Cannabidiol (CBD) Oil Capsules

Sunflower Lecithin Oil in Capsule

PLACEBO COMPARATOR

1-4 capsules daily

Drug: Sunflower Lecithin Oil in Capsule

Interventions

Cannabidiol (CBD) Oil Capsules 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)

Cannabidiol (CBD) Oil Capsules

Sunflower Lecithin Oil in Capsule 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)

Sunflower Lecithin Oil in Capsule

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Physical exam and laboratory findings without clinically significant abnormalities.
• Participants must agree to abstain from recreational cannabis use for the duration of the study.
• 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)
• The ability to comprehend and satisfactorily comply with protocol requirements.
• Written informed consent given prior to entering the baseline period of the study.

You may not qualify if:

• Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
• Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder)will be excluded.
• Participants with a lifetime history of daily cannabis use will be excluded.
• Dose changes of concomitant medication will not be permitted during the study period.
• 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.
• 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.
• 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.
• Participants with a family history of psychosis will be excluded.
• Participants who have a history of adverse reactions to cannabis will be excluded.

Sponsors & Collaborators

• McMaster University: lead
• Tilray: collaborator

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Panic Disorder; Agoraphobia; Anxiety Disorders; Marijuana Abuse

Interventions

Cannabidiol; Oils; Capsules

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael Van Ameringen, MD, FRCPC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 8, 2018
• Study Start: December 15, 2021
• Primary Completion: December 15, 2023
• Study Completion: February 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)