Verified August 2016 by University of Washington
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Bedard-Gilligan, University of Washington
ClinicalTrials.gov Identifier:
NCT02874898
First received: August 16, 2016
Last updated: August 19, 2016
Last verified: August 2016
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.
| Chronic Post-Traumatic Stress Disorder Marijuana Abuse |
Behavioral: Brief Imaginal Exposure |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD |
- Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Defined as completion of less than 5 of 6 sessions of IE treatment
- Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: baseline, 4 week, and 12 Weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: baseline, 4 week, and 12 Weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline, 4 week, and 12 Weeks ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 72 |
| Study Start Date: | June 2016 |
| Estimated Study Completion Date: | May 2019 |
| Estimated Primary Completion Date: | May 2019 (Final data collection date for primary outcome measure) |
| Active Comparator: Heavy marijuana use
Heavy marijuana users with PTSD |
Behavioral: Brief Imaginal Exposure
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it |
| Active Comparator: No marijuana use
Non-marijuana users with PTSD |
Behavioral: Brief Imaginal Exposure
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it |
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.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02874898
| University of Washington | |
| Seattle, Washington, United States, 98105 | |
| Contact: Michele A Bedard-Gilligan, PhD 206-616-4215 mab29@nullu.washington.edu | |
| Principal Investigator: Michele A Bedard-Gilligan, PhD | |
University of Washington
National Institute on Drug Abuse (NIDA)
| Principal Investigator: | Michele A Bedard-Gilligan, PhD | University of Washington |
| Responsible Party: | Michele Bedard-Gilligan, Assistant Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT02874898 History of Changes |
| Other Study ID Numbers: | 51623-EG 1R34DA040034-01A1 |
| Study First Received: | August 16, 2016 |
| Last Updated: | August 19, 2016 |
| Health Authority: | United States: Institutional Review Board |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
| Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Marijuana Abuse Trauma and Stressor Related Disorders |
Mental Disorders Substance-Related Disorders Chemically-Induced Disorders |
ClinicalTrials.gov processed this record on August 25, 2016