Trial Outcomes & Findings for Trial Of NS2359 For The Treatment of Cocaine Dependence (NCT NCT02798627)
NCT ID: NCT02798627
Last Updated: 2021-05-24
Results Overview
Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the NS2359 Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial \[ Time Frame: weeks 6,7.8 of the trial \] Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-05-24
Participant Flow
Recruitment by advertising in local newspapers and radio began in 07/2016 and ended in 12/2018.
Participants had a screening telephone appointment to determine eligibility. If eligible, they were seen at the clinic for history, physical exam and urine drug screen. A positive urine drug screen for a cocaine metabolite (BE) was used as a stratifying variable in randomization.
Participant milestones
| Measure |
NS2359
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
|
Placebo
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
placebo: Placebo pills identical in appearance to the NS2359 will be provided
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Of NS2359 For The Treatment of Cocaine Dependence
Baseline characteristics by cohort
| Measure |
NS2359
n=27 Participants
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
|
Placebo
n=28 Participants
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
placebo: Placebo pills identical in appearance to the NS2359 will be provided
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
n=5 Participants
|
52 years
n=7 Participants
|
53.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Days of cocaine use in past 30
|
9.0 Days
n=5 Participants
|
9.5 Days
n=7 Participants
|
9.0 Days
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the NS2359 Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial \[ Time Frame: weeks 6,7.8 of the trial \] Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.
Outcome measures
| Measure |
NS2359
n=27 Participants
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
|
Placebo
n=28 Participants
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
placebo: Placebo pills identical in appearance to the NS2359 will be provided
|
|---|---|---|
|
The Number of Participants Who Achieved Abstinence From Cocaine During the Last Three Weeks of the Trial
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 8 weeksAs measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving.
Outcome measures
| Measure |
NS2359
n=27 Participants
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
|
Placebo
n=28 Participants
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
placebo: Placebo pills identical in appearance to the NS2359 will be provided
|
|---|---|---|
|
Average Weekly Cocaine Craving Scores NS2359 Group Versus the Placebo Group Comparator [ Time Frame: Once Per Week in Weeks 2 Through 8 ]
|
4.09 score on a scale
Standard Error 0.39
|
3.89 score on a scale
Standard Error 0.33
|
Adverse Events
NS2359
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NS2359
n=27 participants at risk
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
|
Placebo
n=28 participants at risk
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
placebo: Placebo pills identical in appearance to the NS2359 will be provided
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
11.1%
3/27 • Number of events 3 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
0.00%
0/28 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
|
Gastrointestinal disorders
flatulence
|
7.4%
2/27 • Number of events 2 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
3.6%
1/28 • Number of events 1 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
|
Nervous system disorders
sedation
|
11.1%
3/27 • Number of events 3 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
0.00%
0/28 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
|
Vascular disorders
increased blood pressure
|
11.1%
3/27 • Number of events 3 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
0.00%
0/28 • Adverse event data was measured over 12 weeks
Patients completed adverse event forms and answered specific questions about adverse events
|
Additional Information
Kyle Kampman, MD
University of Pennsylvania Perelman School of Medicine
Phone: 2157462764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place