Back to resultsShort-Term Exposure for PTSD (STEP)
Primary Purpose
Chronic Post-Traumatic Stress Disorder, Marijuana Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Imaginal Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Post-Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Heavy marijuana use
No marijuana use
Arm Description
Heavy marijuana users with PTSD
Non-marijuana users with PTSD
Outcomes
Primary Outcome Measures
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
Treatment drop-out
Defined as completion of less than 5 of 6 sessions of IE treatment
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02874898
First Posted
August 16, 2016
Last Updated
August 19, 2022
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02874898
Brief Title
Short-Term Exposure for PTSD
Acronym
STEP
Official Title
Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-Traumatic Stress Disorder, Marijuana Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heavy marijuana use
Arm Type
Active Comparator
Arm Description
Heavy marijuana users with PTSD
Arm Title
No marijuana use
Arm Type
Active Comparator
Arm Description
Non-marijuana users with PTSD
Intervention Type
Behavioral
Intervention Name(s)
Brief Imaginal Exposure
Intervention Description
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it
Primary Outcome Measure Information:
Title
Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
Description
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
Time Frame
12 Weeks
Title
Treatment drop-out
Description
Defined as completion of less than 5 of 6 sessions of IE treatment
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Description
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.
Time Frame
baseline, 4 week, and 12 Weeks
Title
Change in Marijuana Problems Scale (MPS)
Description
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.
Time Frame
baseline, 4 week, and 12 Weeks
Title
Change in Marijuana Frequency and Quantity
Description
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.
Time Frame
baseline, 4 week, and 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele A Bedard-Gilligan, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Short-Term Exposure for PTSD
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