Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

NCT04448808 | Completed Phase 2

• 1 other identifier: THC-PTBS
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 4

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

Keywords

Nightmares; Posttraumatic Stress Disorder; Dronabinol

Outcome Measures

Primary Outcomes (1)

• Frequency and intensity of nightmares

  Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.

  10 weeks

Secondary Outcomes (20)

• Change from baseline of the frequency and intensity of nightmares

  1, 2, 3, 4,6 and 8 weeks

• Change from baseline of the CAPS-5 total score

  6 and 10 weeks

• Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD

  6 and 10 weeks

• Change from baseline of the Montgomery-Åsberg Depression Rating Scale

  4 and 10 weeks

• Weekly mean of change from baseline of daily total sleep time

  during 10 weeks

Study Arms (2)

BX-1 (dronabinol)

EXPERIMENTAL

BX-1

Drug: BX-1

Placebo

PLACEBO COMPARATOR

Placebo of BX-1

Drug: Placebo

Interventions

BX-1 DRUG

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

BX-1 (dronabinol)

Placebo DRUG

Placebo of BX-1, oral solution

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ≥ 26
• At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5
• Men and women between 18 and 65 years of age
• Written informed consent
• 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)
• The patient is not breastfeeding
• Women of child-bearing potential must have a negative urine or serum pregnancy test
• All participants must use highly effective contraception
• 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)

You may not qualify if:

• Lifetime cannabis use disorder
• Current substance/alcohol use disorder (≤ 3 months);
• Acute suicidality;
• Psychotic disorder;
• Bipolar disorder;
• Current anorexia nervosa;
• Current major depressive episodes and a MADRS score \> 29;
• Dementia;
• Trauma-focused psychotherapy four weeks before the trial
• Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening
• Acute or unstable medical illness.
• Epilepsy
• Relevant heart diseases
• Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
• Current or past malignant illness

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Bionorica SE: collaborator

Study Sites (4)

Berlin St. Hedwig

Berlin, 10115, Germany

Location

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

Berlin, 12203, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, 86159, Germany

Location

Related Publications (1)

• 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.

  PMID: 37147642 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Stefan Roepke, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Stefan Roepke, MD

Model Details: Randomized controlled study (double-blind)

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 26, 2020
• Study Start: October 1, 2020
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)