Trial Outcomes & Findings for Ketamine for the Treatment of Opioid Use Disorder and Depression (NCT NCT04177706)

Last Updated: 2024-08-07

Results Overview

Primary outcomes will be 1) the percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Actual time frame of: 23 months.

Results posted on

2024-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Group A (Ketamine) Ketamine Hydrochloride: Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.	Group B (Placebo) Placebo: Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
Overall Study STARTED	11	10
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine for the Treatment of Opioid Use Disorder and Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A (Ketamine) n=11 Participants Ketamine Hydrochloride: Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.	Group B (Placebo) n=10 Participants Placebo: Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.	Total n=21 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	37 years n=7 Participants	36 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Actual time frame of: 23 months.

Population: Outcomes will be cumulatively assessed from the time that the first participant is screened through the time that the last participant completes informed consent. There is only a single cohort (single arm/group) until randomization, which happens at the first interventional visit. Actual 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.

Outcome measures

Outcome measures
Measure	Percentage of Individuals Completing Informed Consent n=153 Participants Percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.	Group B (Placebo) 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	34 Participants	—

PRIMARY outcome

Timeframe: Actual time frame 23 months.

Population: There is only a single cohort (single arm/group) until randomization, which happens at the first interventional visit.

The other primary outcome will be the percentage of individuals that complete informed consent which complete the full interventional protocol.

Outcome measures

Outcome measures
Measure	Percentage of Individuals Completing Informed Consent n=34 Participants Percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.	Group B (Placebo) Placebo: Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
Percentage of Individuals Completing the Full Protocol	11 Participants	—

SECONDARY outcome

Timeframe: Baseline through 4-week interventional visits (8th interventional visit).

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 weeks (8th interventional visit). 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.

Outcome measures

Outcome measures
Measure	Percentage of Individuals Completing Informed Consent n=6 Participants Percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.	Group B (Placebo) n=5 Participants Placebo: Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
Change in Depression Severity	30 score on a scale Standard Deviation 2.8	10.8 score on a scale Standard Deviation 14.1

Adverse Events

Group A (Ketamine)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prinicipal Investigator

Medical University of South Carolina

Phone: 8438761199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place