Trial Outcomes & Findings for An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users (NCT NCT06097676)
NCT ID: NCT06097676
Last Updated: 2024-08-12
Results Overview
Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
ABECD
Period 1: Placebo Period 2: Alprazolam 2 mg Period 3: GE-IR 700 mg Period 4: GE-IR 200 mg Period 5: GE-IR 450 mg
|
AEBDC
Period 1: Placebo Period 2: GE-IR 700 mg Period 3: Alprazolam 2 mg Period 4: GE-IR 450 mg Period 5: GE-IR 200 mg
|
BACED
Period 1: Alprazolam 2 mg Period 2: Placebo Period 3: GE-IR 200 mg Period 4: GE-IR 700 mg Period 5: GE-IR 450 mg
|
BCADE
Period 1: Alprazolam 2 mg Period 2: GE-IR 200 mg Period 3: Placebo Period 4: GE-IR 450 mg Period 5: GE-IR 700 mg
|
CBDAE
Period 1: GE-IR 200 mg Period 2: Alprazolam 2 mg Period 3: GE-IR 450 mg Period 4: Placebo Period 5: GE-IR 700 mg
|
CDBEA
Period 1: GE-IR 200 mg Period 2: GE-IR 450 mg Period 3: Alprazolam 2 mg Period 4: GE-IR 700 mg Period 5: Placebo
|
DCEBA
Period 1: GE-IR 450 mg Period 2: GE-IR 200 mg Period 3: GE-IR 700 mg Period 4: Alprazolam 2 mg Period 5: Placebo
|
DECAB
Period 1: GE-IR 450 mg Period 2: GE-IR 700 mg Period 3: GE-IR 200 mg Period 4: Placebo Period 5: Alprazolam 2 mg
|
EADBC
Period 1: GE-IR 700 mg Period 2: Placebo Period 3: GE-IR 450 mg Period 4: Alprazolam 2 mg Period 5: GE-IR 200 mg
|
EDACB
Period 1: GE-IR 700 mg Period 2: GE-IR 450 mg Period 3: Placebo Period 4: GE-IR 200 mg Period 5: Alprazolam 2 mg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
5
|
5
|
4
|
5
|
4
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users
Baseline characteristics by cohort
| Measure |
Treatment Phase
n=51 Participants
Subjects randomized in the treatment phase
|
|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Sedative Drug Use In the Past 12 Weeks
|
12 times
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phaseMean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo: Placebo
|
Alprazolam 2 mg
n=47 Participants
Alprazolam 2 mg: Oral dose of alprazolam 2 mg
|
GE-IR 200 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg: Oral dose of GE-IR 200 mg
|
GE-IR 450 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg: Oral dose of GE-IR 450 mg
|
GE-IR 700 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg: Oral dose of GE-IR 700 mg
|
|---|---|---|---|---|---|
|
Drug Liking "at This Moment" Visual Analog Scale (VAS)
|
54.1 score on a scale
Standard Error 1.47
|
83.8 score on a scale
Standard Error 1.93
|
58.9 score on a scale
Standard Error 1.93
|
58.4 score on a scale
Standard Error 1.5
|
68.5 score on a scale
Standard Error 2.62
|
SECONDARY outcome
Timeframe: approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phaseMean difference in Emax for Overall Drug Liking ("Overall, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo: Placebo
|
Alprazolam 2 mg
n=47 Participants
Alprazolam 2 mg: Oral dose of alprazolam 2 mg
|
GE-IR 200 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg: Oral dose of GE-IR 200 mg
|
GE-IR 450 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg: Oral dose of GE-IR 450 mg
|
GE-IR 700 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg: Oral dose of GE-IR 700 mg
|
|---|---|---|---|---|---|
|
Overall Drug Liking VAS
|
54.2 score on a scale
Standard Error 1.71
|
86.6 score on a scale
Standard Error 2.12
|
62.8 score on a scale
Standard Error 2.56
|
61.7 score on a scale
Standard Error 2.4
|
68.2 score on a scale
Standard Error 3.26
|
SECONDARY outcome
Timeframe: approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phaseMean difference in Emax for Take Drug Again ("I would take this drug again"), assessed on a bipolar (0 to 100 points; 0: Definitely would not 50: Neither would nor would not, 100: Definitely would) VAS.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo: Placebo
|
Alprazolam 2 mg
n=47 Participants
Alprazolam 2 mg: Oral dose of alprazolam 2 mg
|
GE-IR 200 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg: Oral dose of GE-IR 200 mg
|
GE-IR 450 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg: Oral dose of GE-IR 450 mg
|
GE-IR 700 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg: Oral dose of GE-IR 700 mg
|
|---|---|---|---|---|---|
|
Take Drug Again VAS
|
55.2 score on a scale
Standard Error 2.55
|
87.4 score on a scale
Standard Error 2.14
|
64.6 score on a scale
Standard Error 2.82
|
65.4 score on a scale
Standard Error 2.76
|
71.4 score on a scale
Standard Error 3.52
|
SECONDARY outcome
Timeframe: within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phaseMean difference in Emax for High ("At this moment, I'm feeling high"), assessed on a unipolar (0 to 100 points; 0: Not at all, 100: Extremely) VAS.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo: Placebo
|
Alprazolam 2 mg
n=47 Participants
Alprazolam 2 mg: Oral dose of alprazolam 2 mg
|
GE-IR 200 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg: Oral dose of GE-IR 200 mg
|
GE-IR 450 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg: Oral dose of GE-IR 450 mg
|
GE-IR 700 mg
n=47 Participants
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg: Oral dose of GE-IR 700 mg
|
|---|---|---|---|---|---|
|
High VAS
|
5.2 score on a scale
Standard Error 2.61
|
65.5 score on a scale
Standard Error 4.05
|
11.7 score on a scale
Standard Error 2.79
|
12.8 score on a scale
Standard Error 2.91
|
31.6 score on a scale
Standard Error 4.56
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alprazolam 2 mg
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
GE-IR 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GE-IR 450 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GE-IR 700 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo: Placebo
|
Alprazolam 2 mg
n=50 participants at risk
Alprazolam 2 mg: Oral dose of alprazolam 2 mg
|
GE-IR 200 mg
n=49 participants at risk
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg: Oral dose of GE-IR 200 mg
|
GE-IR 450 mg
n=51 participants at risk
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg: Oral dose of GE-IR 450 mg
|
GE-IR 700 mg
n=50 participants at risk
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg: Oral dose of GE-IR 700 mg
|
|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/49 • The maximum duration of subject participation was approximately 49 days, including screening.
|
68.0%
34/50 • Number of events 34 • The maximum duration of subject participation was approximately 49 days, including screening.
|
6.1%
3/49 • Number of events 3 • The maximum duration of subject participation was approximately 49 days, including screening.
|
5.9%
3/51 • Number of events 3 • The maximum duration of subject participation was approximately 49 days, including screening.
|
10.0%
5/50 • Number of events 5 • The maximum duration of subject participation was approximately 49 days, including screening.
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
4.0%
2/50 • Number of events 2 • The maximum duration of subject participation was approximately 49 days, including screening.
|
2.0%
1/49 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
2.0%
1/51 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
6.0%
3/50 • Number of events 3 • The maximum duration of subject participation was approximately 49 days, including screening.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • The maximum duration of subject participation was approximately 49 days, including screening.
|
12.0%
6/50 • Number of events 6 • The maximum duration of subject participation was approximately 49 days, including screening.
|
0.00%
0/49 • The maximum duration of subject participation was approximately 49 days, including screening.
|
2.0%
1/51 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
6.0%
3/50 • Number of events 3 • The maximum duration of subject participation was approximately 49 days, including screening.
|
|
Psychiatric disorders
Euphoric mood
|
2.0%
1/49 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
30.0%
15/50 • Number of events 15 • The maximum duration of subject participation was approximately 49 days, including screening.
|
4.1%
2/49 • Number of events 2 • The maximum duration of subject participation was approximately 49 days, including screening.
|
0.00%
0/51 • The maximum duration of subject participation was approximately 49 days, including screening.
|
10.0%
5/50 • Number of events 5 • The maximum duration of subject participation was approximately 49 days, including screening.
|
|
General disorders
Fatigue
|
0.00%
0/49 • The maximum duration of subject participation was approximately 49 days, including screening.
|
6.0%
3/50 • Number of events 3 • The maximum duration of subject participation was approximately 49 days, including screening.
|
0.00%
0/49 • The maximum duration of subject participation was approximately 49 days, including screening.
|
0.00%
0/51 • The maximum duration of subject participation was approximately 49 days, including screening.
|
2.0%
1/50 • Number of events 1 • The maximum duration of subject participation was approximately 49 days, including screening.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place