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Cannabidiol enhancement of exposure therapy in patients with phobias.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28305
Enrollment
72
Registered
2015-03-13
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phobic anxiety disorders, fobische angststoornissen

Interventions

Cannabidiol (capsule) or placebo (capsule), in combination with exposure therapy with response prevention (ERP)

Sponsors

Utrecht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients will be invited to participate when they fulfill the diagnoses mentioned here-above, and provided that they have not or only partially responded to evidence-based treatment (either a full treatment with an SSRI (at least 12 weeks of sufficient dose) and/or at least 10 sessions of cognitive behavioural therapy) in the year preceding referral to the outpatient clinics.

Exclusion criteria

Exclusion criteria: Patients with co-morbid severe psychiatric disorders diagnosed with the SCID-I (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ<80) or inability to adequately read or speak Dutch will be excluded (assessed using a neuropsychological Test (NLV; Schmand et al. 1992), as well as persons with (a history of) epilepsy or brain damage, renal or liver abnormalities, and a history of allergies to medication (adverse reactions or rash). Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, contunued use of SSRIs will be permitted, provided that dosages are kept constant during the study. Lastly pregnant or breastfeeding women will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the fear questionnaire (FQ, Marks and Mathews 1979).

Secondary

MeasureTime frame
At all timepoints clinical questionnaires are administered: Beck Anxiety Inventory, Beck Depression Inventory, Body Sensations Questionnaire, Social Phobia and Anxiety Inventory, Treatment inventory of costs in Psychiatric patients, and EuroQol five dimensions. This also includes the Panic Disorder Severity Scale, Mobility Inventory and Agoraphobic Cognitions Questionnaire for patients with panic disorder with agoraphobia, and the Liebowitz Social Anxiety Scale for social phobia patients. The Clinical Global Impression, Subjective Units of Distress Scale and assessment of the quality of the sessions are administered weekly. Furthermore, an experimental assessment of fear learning using a fear conditioning paradigm is done, and blood is drawn twice to investigate CBD blood levels and (epi)genetics.

Contacts

Public ContactFebe van der Flier

Heidelberglaan 1

F.E.vanderFlier@uu.nl0634852440

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)