Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

NCT ID: NCT04448808

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-01-02

Brief Summary

This randomized controlled exploratory phase II trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BX-1 (dronabinol)

BX-1

Group Type: EXPERIMENTAL

BX-1

Intervention Type: DRUG

BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.

Placebo

Placebo of BX-1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of BX-1, oral solution

Interventions

BX-1

BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.

Intervention Type: DRUG

Placebo

Placebo of BX-1, oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ≥ 26

2. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5

3. Men and women between 18 and 65 years of age

4. Written informed consent

5. The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)

6. The patient is not breastfeeding

7. Women of child-bearing potential must have a negative urine or serum pregnancy test

8. All participants must use highly effective contraception

9. The patient received stable pharmacological medication for at least 4 weeks prior to study entry (any changes in medication dose or frequency of therapy must be answered with no)

Exclusion Criteria

1. Lifetime cannabis use disorder

2. Current substance/alcohol use disorder (≤ 3 months);

3. Acute suicidality;

4. Psychotic disorder;

5. Bipolar disorder;

6. Current anorexia nervosa;

7. Current major depressive episodes and a MADRS score > 29;

8. Dementia;

9. Trauma-focused psychotherapy four weeks before the trial

10. Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening

11. Acute or unstable medical illness.

12. Epilepsy

13. Relevant heart diseases

14. Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection

15. Current or past malignant illness

16. The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons

17. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial

18. The patient is legally detained in an official institution

19. The patient does have a known allergy or contraindication against Dronabinol

20. The patient does have clinically significant abnormalities in 12-lead ECG

21. The patient does have clinically significant laboratory abnormalities

22. The patient did participate in other interventional trials during the 3 months before and at the time of this trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bionorica SE

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan Roepke

Prof. Dr. Stefan Roepke, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Roepke, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Berlin St. Hedwig

Berlin, , Germany

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie

Berlin, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, , Germany

Countries

Germany

References

Roepke S, Schoofs N, Priebe K, Wulfing F, Schmahl C, Rohle R, Zahringer J, Lotter T, Otte C, Koglin S. Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial). BMC Psychiatry. 2023 May 5;23(1):319. doi: 10.1186/s12888-023-04818-5.

Reference Type: DERIVED

PMID: 37147642 (View on PubMed)

Other Identifiers

THC-PTBS

Identifier Type: -

Identifier Source: org_study_id