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Trial record 35 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Short-Term Exposure for PTSD (STEP)

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ClinicalTrials.gov Identifier: NCT02874898
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Bedard-Gilligan, University of Washington

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.

Condition or disease Intervention/treatment Phase
Chronic Post-Traumatic Stress Disorder Marijuana Abuse Behavioral: Brief Imaginal Exposure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Treatment drop-out [ Time Frame: 2 Weeks ]
    Defined as completion of less than 5 of 6 sessions of IE treatment


Secondary Outcome Measures :
  1. Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: baseline, 4 week, and 12 Weeks ]
    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.

  2. Change in Marijuana Problems Scale (MPS) [ Time Frame: baseline, 4 week, and 12 Weeks ]
    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.

  3. Change in Marijuana Frequency and Quantity [ Time Frame: baseline, 4 week, and 12 Weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
  2. Between the age of 18 and 65;
  3. Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
  4. Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder

Exclusion Criteria:

  1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
  2. 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).
  3. Unwilling or unable to discontinue current trauma-focused psychotherapy
  4. Any previous experience with prolonged exposure (PE) treatment
  5. No clear trauma memory or trauma before age 3
  6. Unstable dose of psychotropic medications in the prior 3 months
  7. Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).
  8. Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874898


Contacts
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Contact: Michele A Bedard-Gilligan, PhD 2066853617 uwstep@uw.edu
Contact: Heidi J Ojalehto, BS 2066853617 hjo22@u.washington.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Michele A Bedard-Gilligan, PhD    206-685-3617      
Principal Investigator: Michele A Bedard-Gilligan, PhD         
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Michele A Bedard-Gilligan, PhD University of Washington

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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 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Marijuana Abuse
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders