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Completed

NCT Number: NCT02874898

Short-Term Exposure for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Imaginal Exposure

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD

Acronym: STEP

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2016
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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