Cannabidiol enhancement of exposure therapy in treatment refractory patients with phobias.

Phase 3

Completed

Conditions: Phobic anxiety disorders
10002861

Registration Number: NL-OMON44760

Lead Sponsor: niversiteit Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

Patients will be invited to participate when they fulfill the DSM IV criteria for a diagnosis of either generalized social phobia or panic disorder with agoraphobia, and provided that they have not or only partially responded to treatment in the year preceding referral to the outpatient clinics. We will use the following definition of patients who only partially responded to treatment:
a) having been treated in the past year for the same symptoms (psycho- or pharmacotherapy) and/or
b) specifically referred to second-line treatment

Exclusion Criteria

Patients with co-morbid severe psychiatric disorders (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ<80), autism (AQ>32) or inability to adequately read or speak Dutch will be excluded, as well as persons with (a history of) epilepsy, cardiovascular disease or brain damage, renal or liver abnormalities, and a history of allergies on medication (adverse reactions or rash).
Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, since benzodiazepine use might hamper the ERP effect. Use of serotonergic antidepressants will be permitted, provided that dosages are kept constant during the study. Use of drugs (among others THC, XTC, cocaine) of is not permitted from 2 months before the start of the treatment until the end of the study.
Lastly pregnant or breastfeeding women will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main parameter regarding treatment effects on anxiety symptoms are measured at<br /><br>baseline, after every ERP-session, in the week after session 4 (at<br /><br>mid-treatment), in the week after session 8 (at post treatment) and at 3, and 6<br /><br>months follow up. Secondary parameters (effects on other symptom<br /><br>questionnaires, on fear extinction in a laboratory assessment, learning and<br /><br>habituation and effects on health care use, costs, quality of life and loss of<br /><br>work productivity) are measured at baseline, and directly post treatment (one<br /><br>week after 8 exposure sessions), and a part of these are also monitored at 3,<br /><br>and 6 months follow-up. Further, 10 ml of blood to extract DNA will be drawn<br /><br>through venapuncture twice, before the first and the eight treatment session,<br /><br>in order to determine CBD-related genetic polymorphisms, to establish blood<br /><br>cannabidiol levels, and to perform epigenetic analyses.</p><br>

Secondary Outcome Measures