Chronic Post-Traumatic Stress DisorderSTEPNCT02874898
Short-Term Exposure for PTSD
A study testing Brief Imaginal Exposure in people with Chronic Post-Traumatic Stress Disorder and Marijuana Abuse, run by University of Washington at 1 site in United States.
Trial summary
This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Post-Traumatic Stress Disorder, Marijuana Abuse
- What is being tested?
- Brief Imaginal Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
- Between the age of 18 and 65;
- Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
- Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder
Who cannot join
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
- Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- Unwilling or unable to discontinue current trauma-focused psychotherapy
- Any previous experience with prolonged exposure (PE) treatment
- No clear trauma memory or trauma before age 3
- Unstable dose of psychotropic medications in the prior 3 months
- Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).
- Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.
Read the detailed description
In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. To examine real world therapeutic implications, we will also examine how individuals with PTSD and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment. Throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. Independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.
- Being tested
- Brief Imaginal Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Imaginal ExposureBehavioural
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it
| Study group | Role | What they receive |
|---|---|---|
| Heavy marijuana use | Active comparator | Heavy marijuana users with PTSD Receives: Behavioral: Brief Imaginal Exposure |
| No marijuana use | Active comparator | Non-marijuana users with PTSD Receives: Behavioral: Brief Imaginal Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in PTSD symptoms
Measured: 12 Weeks
Treatment drop-out
Defined as completion of less than 5 of 6 sessions of IE treatment
Measured: 2 Weeks
Secondary outcomes (3)
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)
The QIDS-SR16 assesses symptoms of depression as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in depression symptoms.
Measured: baseline, 4 week, and 12 Weeks
Change in Marijuana Problems Scale (MPS)
The MPS is a self-report that assesses the impacts of marijuana on various areas of life, including motivation and productivity, social relationships, work and finances, self-esteem, memory impairment, legal problems, and physical health. The MPS is administered at baseline, 4 week and 12 week follow up to assess change in marijuana abuse.
Measured: baseline, 4 week, and 12 Weeks
Change in Marijuana Frequency and Quantity
The Marijuana Frequency and Quantity Scale assesses the frequency and quantity of marijuana use and is administered at baseline, 4 week and 12 week follow up to assess changes in marijuana use.
Measured: baseline, 4 week, and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michele Bedard-Gilligan, University of Washington
- Investigators
- Michele A Bedard-Gilligan, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874898
- Sponsor's protocol ID
- STUDY00001289
- Other IDs
- 1R34DA040034-01A1
- Acronym
- STEP
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2016
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
- ClinicalTrials.gov ID
- NCT02874898
- Acronym / sponsor ID
- STEP / STUDY00001289
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2016 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.
Detailed description
In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. To examine real world therapeutic implications, we will also examine how individuals with PTSD and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment. Throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. Independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy marijuana use | Active comparator | Behavioral: Brief Imaginal ExposureHeavy marijuana users with PTSD |
| No marijuana use | Active comparator | Behavioral: Brief Imaginal ExposureNon-marijuana users with PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
- Between the age of 18 and 65;
- Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
- Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder
Key exclusion criteria (8 listed)
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
- Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- Unwilling or unable to discontinue current trauma-focused psychotherapy
- Any previous experience with prolonged exposure (PE) treatment
- No clear trauma memory or trauma before age 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Imaginal ExposurePsychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it | Behavioural | Heavy marijuana use, No marijuana use |
Primary outcome
Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
Time frame: 12 Weeks
The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in PTSD symptoms
Treatment drop-out
Time frame: 2 Weeks
Defined as completion of less than 5 of 6 sessions of IE treatment
3 secondary outcomes
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Time frame: baseline, 4 week, and 12 Weeks
Change in Marijuana Problems Scale (MPS)
Time frame: baseline, 4 week, and 12 Weeks
Change in Marijuana Frequency and Quantity
Time frame: baseline, 4 week, and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele A Bedard-Gilligan, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Imaginal Exposure in people with Chronic Post-Traumatic Stress Disorder and Marijuana Abuse, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.