KAP for Depression in Abstinent Opioid Users (NCT05193318) | Clinical Trial Compass
TerminatedPhase 2
KAP for Depression in Abstinent Opioid Users
Stopped: Primary Investigator leaving institution
United States5 participantsStarted 2022-01-13
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Between the ages of 18 to 64 years old.
✓. Able to provide informed consent.
✓. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview.
✓. Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression).
✓. Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview.
✓. Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.
Exclusion criteria
✕. They are considered an immediate suicide risk by clinician assessment, self-reports a suicide attempt within the past year, or felt to be likely to require hospitalization during the study.
✕. Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
What they're measuring
1
Montgomery Asberg Depression Rating Scale
Timeframe: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
✕. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
✕. Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.
✕. Subjects who report use of ketamine \>20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission.
✕. Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the interventional phase of the study.
✕. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg.
✕. A history of allergic or other adverse reaction to ketamine (or its excipients).