Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

August 8, 2025 updated by: Stefan Roepke, Charite University, Berlin, Germany

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol: A Randomized Controlled Study (THC PTSD-trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Berlin St. Hedwig
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Mannheim, Germany, 86159
        • Zentralinstitut für Seelische Gesundheit Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BX-1 (dronabinol)
BX-1
Drug: BX-1
BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
Placebo Comparator: Placebo
Placebo of BX-1
Drug: Placebo
Placebo of BX-1, oral solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency and intensity of nightmares
Time Frame: 10 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline of the frequency and intensity of nightmares
Time Frame: 1, 2, 3, 4,6 and 8 weeks
Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8.
1, 2, 3, 4,6 and 8 weeks
Change from baseline of the CAPS-5 total score
Time Frame: 6 and 10 weeks
Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week)
6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD
Time Frame: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms)
6 and 10 weeks
Change from baseline of the Montgomery-Åsberg Depression Rating Scale
Time Frame: 4 and 10 weeks
Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)
4 and 10 weeks
Weekly mean of change from baseline of daily total sleep time
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries
during 10 weeks
Weekly mean of change from baseline of the patients sleep onset latency at night
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries
during 10 weeks
Weekly mean of change from baseline of the patients recuperation of night sleep
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), assessed with sleep diaries
during 10 weeks
Weekly mean of change from baseline of the patients time awake at night
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries
during 10 weeks
Weekly mean of change from baseline of the patients number of nightmares last night
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries
during 10 weeks
Weekly mean of change from baseline of the patients intensity of nightmares
Time Frame: during 10 weeks
Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries
during 10 weeks
Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5
Time Frame: 6 and 10 weeks
Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5)
6 and 10 weeks
Change from baseline of the Borderline Symptom List 23
Time Frame: 6 and 10 weeks
Change from baseline of the Borderline Symptom List 23 (BSL-23) score
6 and 10 weeks
Change from baseline of the Health-Related Quality of Life
Time Frame: 6 and 10 weeks
Change from baseline of the Health-Related Quality of Life (EQ-5D) score
6 and 10 weeks
Overall patients status measured by the Patient Global Impression of Change
Time Frame: 6 and 10 weeks
Overall patients status measured by the Patient Global Impression of Change (PGIC)
6 and 10 weeks
Change from baseline of the Social and Occupational Functioning Assessment Scale
Time Frame: 6 and 10 weeks
Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)
6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index
Time Frame: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)
6 and 10 weeks
Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire
Time Frame: 6 and 10 weeks
Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)
6 and 10 weeks
Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist
Time Frame: 6 and 10 weeks and Follow- Up Visit 9
Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC)
6 and 10 weeks and Follow- Up Visit 9
Responder analysis: proportion of patients showing improvement in nightmares
Time Frame: 10 weeks
Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 ≥50% assessed at the end of treatment
10 weeks
Remitter analysis: proportion of patients showing full remission of nightmares
Time Frame: 10 weeks
Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bionorica SE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Roepke, MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THC-PTBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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