Trial Outcomes & Findings for Suvorexant for Opioid/Stimulant Co-use (NCT NCT05546515)

NCT ID: NCT05546515

Last Updated: 2025-12-23

Results Overview

Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 30 days post-randomization

Results posted on

2025-12-23

Participant Flow

A total of 41 individuals attended a screening visit. Of the 20 individuals enrolled (i.e., initially determined as eligible to be scheduled for randomization), 5 declined enrollment and 2 no longer met criteria at the randomization visit and were not randomized. A total of 13 individuals were randomized. 12 of these individuals completed the study, one individual did not complete.

Participant milestones

Participant milestones
Measure	Suvorexant 20mg Suvorexant	Placebo Placebo oral capsules
Overall Study STARTED	6	7
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants (one in each group) do not have data collected on this scale at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=7 Participants Placebo oral capsules	Total n=13 Participants Total of all reporting groups
Age, Continuous	43.67 years STANDARD_DEVIATION 9.54 • n=6 Participants	49.14 years STANDARD_DEVIATION 9.19 • n=7 Participants	46.62 years STANDARD_DEVIATION 9.39 • n=13 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	5 Participants n=7 Participants	9 Participants n=13 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	2 Participants n=7 Participants	4 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	2 Participants n=6 Participants	4 Participants n=7 Participants	6 Participants n=13 Participants
Race (NIH/OMB) White	4 Participants n=6 Participants	3 Participants n=7 Participants	7 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Insomnia Severity Index (ISI)	15.67 score on a scale STANDARD_DEVIATION 6.71 • n=6 Participants	12.29 score on a scale STANDARD_DEVIATION 9.62 • n=7 Participants	13.84 score on a scale STANDARD_DEVIATION 8.25 • n=13 Participants
Total Sleep Time (TST)	394 minutes STANDARD_DEVIATION 104.31 • n=5 Participants • Two participants (one in each group) do not have data collected on this scale at baseline	385 minutes STANDARD_DEVIATION 120.62 • n=6 Participants • Two participants (one in each group) do not have data collected on this scale at baseline	389.09 minutes STANDARD_DEVIATION 107.93 • n=11 Participants • Two participants (one in each group) do not have data collected on this scale at baseline
Opioid Craving Visual Analog Scale (VAS)	39.43 units on a scale STANDARD_DEVIATION 23.90 • n=6 Participants	33.77 units on a scale STANDARD_DEVIATION 34.22 • n=7 Participants	36.38 units on a scale STANDARD_DEVIATION 28.85 • n=13 Participants
Cocaine Craving VAS,	44.27 units on a scale STANDARD_DEVIATION 28.16 • n=6 Participants	45.49 units on a scale STANDARD_DEVIATION 30.28 • n=7 Participants	44.92 units on a scale STANDARD_DEVIATION 28.09 • n=13 Participants
Perceived Stress Scale	18.83 units on a scale STANDARD_DEVIATION 10.34 • n=6 Participants	19.14 units on a scale STANDARD_DEVIATION 10.67 • n=7 Participants	19 units on a scale STANDARD_DEVIATION 10.07 • n=13 Participants

PRIMARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected.

Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Opioid Use: Proportion of Positive Urine Drug Screens (UDS)	0.83 Proportion of urine drug screens Standard Deviation 0.41	0.67 Proportion of urine drug screens Standard Deviation 0.52

PRIMARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected.

Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Cocaine Use: Proportion of Positive UDS Screens	0.83 Proportion of urine drug screens Standard Deviation 0.41	0.97 Proportion of urine drug screens Standard Deviation 0.07

SECONDARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected, leaving six participants in each group.

Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia.

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Insomnia Severity Regression Slope	-0.55 score on a scale/day Interval -1.02 to -0.08	-0.16 score on a scale/day Interval -0.64 to 0.33

SECONDARY outcome

Timeframe: Up to 30 days post-randomization

Population: Two participants did not have baseline data on TST and could not be included in the analysis. One additional participant in the placebo group discontinued following randomization and did not have data collected.

Regression slope of TST scores over scheduled study visits up to 30 days post-randomization.

Outcome measures

Outcome measures
Measure	Suvorexant n=5 Participants 20mg Suvorexant	Placebo n=5 Participants Placebo oral capsules
Total Sleep Time (TST) Regression Slope	11.68 score on a scale/day Interval -4.35 to 27.7	9.37 score on a scale/day Interval -7.93 to 26.7

SECONDARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected.

Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Opioid Craving Visual Analog Scale (VAS) Regression Slope	-1.76 score on a scale/day Interval -5.65 to 2.12	-1.46 score on a scale/day Interval -5.43 to 2.51

SECONDARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected.

Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Cocaine Craving Visual Analog Scale (VAS) Regression Slope	-0.60 score on a scale/day Interval -2.66 to 1.46	-0.71 score on a scale/day Interval -2.86 to 1.44

SECONDARY outcome

Timeframe: Up to 30 days post-randomization

Population: One participant in the placebo group discontinued following randomization and did not have data collected.

Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress.

Outcome measures

Outcome measures
Measure	Suvorexant n=6 Participants 20mg Suvorexant	Placebo n=6 Participants Placebo oral capsules
Perceived Stress Scale Regression Slope	-0.19 score on a scale/day Interval -0.62 to 0.24	0.19 score on a scale/day Interval -0.26 to 0.64

Adverse Events

Suvorexant

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Suvorexant n=6 participants at risk 20mg Suvorexant	Placebo n=7 participants at risk Placebo oral capsules
General disorders Edema	16.7% 1/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
General disorders Headache	16.7% 1/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
Cardiac disorders Hypertension	66.7% 4/6 • From enrollment to end of follow-up, up to 30 days	71.4% 5/7 • From enrollment to end of follow-up, up to 30 days
Cardiac disorders Tachycardia	50.0% 3/6 • From enrollment to end of follow-up, up to 30 days	42.9% 3/7 • From enrollment to end of follow-up, up to 30 days
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
Gastrointestinal disorders Appetite increased	16.7% 1/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
Gastrointestinal disorders Nausea	0.00% 0/6 • From enrollment to end of follow-up, up to 30 days	14.3% 1/7 • From enrollment to end of follow-up, up to 30 days
General disorders Toothache	33.3% 2/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
Nervous system disorders Drowsiness	66.7% 4/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days
Skin and subcutaneous tissue disorders Skin rash	33.3% 2/6 • From enrollment to end of follow-up, up to 30 days	0.00% 0/7 • From enrollment to end of follow-up, up to 30 days

Additional Information

Jennifer Ellis

Johns Hopkins School if Medicine

Phone: 4105506346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place