Ketamine for the Treatment of Opioid Use Disorder and Depression
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|ClinicalTrials.gov Identifier: NCT04177706|
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Depression Opioid-use Disorder Opioid Abuse||Drug: Ketamine Hydrochloride Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Ketamine for the Treatment of Concurrent Opioid Use Disorder and Major Depressive Disorder|
|Actual Study Start Date :||December 17, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
|Experimental: Group A (Ketamine)||
Drug: Ketamine Hydrochloride
Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.
|Placebo Comparator: Group B (Placebo)||
Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
- Percentage of Individuals Completing Informed Consent [ Time Frame: Outcomes will be cumulatively assessed from the time that the first participant is screened through the time that the last participant is enrolled. Estimated time frame of: 23 months. ]Primary outcomes will be 1) the percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.
- Percentage of Individuals Completing the Full Protocol [ Time Frame: Outcomes will be cumulatively assessed from the time that the first participant completes informed consent through the time that the last participant completes the final follow-up visit. Estimated time frame of: 23 months. ]The other primary outcome will be the percentage of individuals that complete informed consent which complete the full protocol.
- Change in Depression Severity [ Time Frame: Baseline through 4 week follow-up. ]Secondary outcomes will include changes in depression severity (as measured on the Montgomery-Asberg Depression Rating Scale), which will be calculated as a change from baseline to 4-week followup. Montgomery Asberg Depression Rating Scale (MADRS; Montgomery, 1979). 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.
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): NCT04177706
|Contact: Melissa Michelfirstname.lastname@example.org|
|Principal Investigator:||Jennifer Jones, MD||Medical University of South Carolina|