Trial Outcomes & Findings for Suvorexant and Cocaine (NCT NCT03937986)
NCT ID: NCT03937986
Last Updated: 2023-02-09
Results Overview
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
12 times over approximately 1 month inpatient admission.
Results posted on
2023-02-09
Participant Flow
Participant milestones
| Measure |
Subjects Included in Analysis
This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions \[0, 5, 10 and 20 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Subjects Included in Analysis
This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions \[0, 5, 10 and 20 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here.
|
|---|---|
|
Overall Study
COVID-19 Pandemic
|
1
|
Baseline Characteristics
Suvorexant and Cocaine
Baseline characteristics by cohort
| Measure |
Subjects Included in Analysis
n=8 Participants
This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions \[0, 5, 10 and 20 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here.
|
|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 times over approximately 1 month inpatient admission.Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
Outcome measures
| Measure |
Dose Condition 1
n=8 Participants
0 mg/70 kg IV Cocaine and 0 mg/day Oral Suvorexant
|
Dose Condition 2
n=8 Participants
10 mg/70 kg IV Cocaine and 0 mg/day Oral Suvorexant
|
Dose Condition 3
n=8 Participants
30 mg/70 kg IV Cocaine and 0 mg/day Oral Suvorexant
|
Dose Condition 4
n=7 Participants
0 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant
|
Dose Condition 5
n=7 Participants
10 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant
|
Dose Condition 6
n=7 Participants
30 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant
|
Dose Condition 7
n=8 Participants
0 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant
|
Dose Condition 8
n=8 Participants
10 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant
|
Dose Condition 9
n=7 Participants
30 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant
|
Dose Condition 10
n=7 Participants
0 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant
|
Dose Condition 11
n=7 Participants
10 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant
|
Dose Condition 12
n=7 Participants
30 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reinforcing Effects of Cocaine
|
1.3 Number of Cocaine Choices
Standard Error 3.5
|
5.0 Number of Cocaine Choices
Standard Error 5.3
|
8.3 Number of Cocaine Choices
Standard Error 3.
|
0 Number of Cocaine Choices
Standard Error 0
|
3.7 Number of Cocaine Choices
Standard Error 8.4
|
8.4 Number of Cocaine Choices
Standard Error 2.7
|
1.3 Number of Cocaine Choices
Standard Error 3.5
|
8.1 Number of Cocaine Choices
Standard Error 3.7
|
9.3 Number of Cocaine Choices
Standard Error 1.9
|
0.4 Number of Cocaine Choices
Standard Error 1.1
|
6.6 Number of Cocaine Choices
Standard Error 4.7
|
8.7 Number of Cocaine Choices
Standard Error 1.9
|
Adverse Events
Subjects Included in Analysis
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Included in Analysis
n=8 participants at risk
This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions \[0, 5, 10 and 20 mg\] and intravenous cocaine doses \[0, 10 and 30 mg/70 kg\]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here.
|
|---|---|
|
Cardiac disorders
Elevated Heart Rate
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Cardiac disorders
Elevated Blood Pressure
|
25.0%
2/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Burning Sensation
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
IV Needle Infiltration
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Hand Swelling
|
25.0%
2/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Arm Soreness
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Gastrointestinal disorders
Saline Taste from IV Flush
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Increased Dream Activity
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
|
Nervous system disorders
Increased Sleep
|
12.5%
1/8 • 32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place