Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
Overview
- Phase
- Phase 2
- Intervention
- Ketamine-assisted psychotherapy
- Conditions
- Opioid Use Disorder, Severe, in Sustained Remission
- Sponsor
- Medical University of South Carolina
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Montgomery Asberg Depression Rating Scale
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.
Investigators
Eric Dobson
Principal Investigator
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketamine-assisted psychotherapy
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Intervention: Ketamine-assisted psychotherapy
Outcomes
Primary Outcomes
Montgomery Asberg Depression Rating Scale
Time Frame: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide. Lower scores are better (less depression).
Secondary Outcomes
- Beck Depression Inventory(Change from baseline measured at week 1-9, 10, 12, and 16)
- Visual Analog Scale (VAS)(Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16)
- Generalized Anxiety Disorder-7 (GAD-7)(Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16.)
- Mystical Experience Questionnaire (MEQ)(Measured at week 1-8)
- Brief Pain Inventory (BPI)(Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16)
- PTSD Checklist (PCL-5; PTSD Checklist 5)(Measured at week 1-9, 10, 12, and 16)
- Timeline Follow-back (TLFB)(Measured at week 1-9, 10, 12, and 16)