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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04569760
Study type	Interventional
Source	McMaster University
Contact
Status	Withdrawn
Phase	Phase 3
Start date	April 2021
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03420456` - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Withdrawn	`NCT02382224` - Worry Exposure for Generalized Anxiety Disorder	N/A
Completed	`NCT02306356` - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting	N/A
Completed	`NCT02256566` - Cognitive Training for Mood and Anxiety Disorders	N/A
Completed	`NCT01958788` - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder	N/A
Completed	`NCT01681329` - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder	N/A
Completed	`NCT01337713` - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)	N/A
Completed	`NCT01342120` - PHARMO Institute Seroquel Safety Study	N/A
Completed	`NCT01201967` - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients	Phase 4
Completed	`NCT01203293` - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector	Phase 1
Completed	`NCT00961298` - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder	Phase 4
Completed	`NCT01971203` - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat	N/A
Completed	`NCT00711737` - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months	N/A
Completed	`NCT00744627` - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.	Phase 3
Terminated	`NCT01244711` - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines	Phase 4
Completed	`NCT00525226` - Evaluating the Effects of Stress in Pregnancy	N/A
Completed	`NCT00537615` - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers	Phase 1
Completed	`NCT00515242` - Therapeutic Massage for Generalized Anxiety Disorder	Phase 1/Phase 2
Completed	`NCT00368745` - Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.	Phase 3