Trial Outcomes & Findings for Glutamatergic Modulation of Cocaine-related Deficits (NCT NCT01790490)
NCT ID: NCT01790490
Last Updated: 2019-04-30
Results Overview
Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline and 24 hours after infusion
Results posted on
2019-04-30
Participant Flow
Participants were recruited using advertisements and were seen at NYSPI.
Participants were excluded if they could not comply with study procedures or if they were found to be ineligible.
Participant milestones
| Measure |
K1, LZP, and K2
Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
|
LZP, K1, and K2
LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
|
K1, K2, and LZP
K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamatergic Modulation of Cocaine-related Deficits
Baseline characteristics by cohort
| Measure |
K1, LZP, and K2
n=3 Participants
Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
|
LZP, K1, and K2
n=3 Participants
LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
|
K1, K2, and LZP
n=2 Participants
K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 9 • n=99 Participants
|
48.2 years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
44.2 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
47.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
8 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 hours after infusionSerial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.
Outcome measures
| Measure |
Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)
n=8 Participants
Ketamine 0.41 mg/kg infused over 52 min (K1)
Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg
|
Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)
n=8 Participants
Ketamine 0.71 mg/kg infused over 52 min (K2)
Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings.
|
Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)
n=8 Participants
Lorazepam 2 mg infused over 52 minutes (LZP)
Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control.
|
|---|---|---|---|
|
Change in Cue Reactivity
|
126 units on a scale (0-200), high is worse
Standard Error 66
|
18 units on a scale (0-200), high is worse
Standard Error 13
|
16 units on a scale (0-200), high is worse
Standard Error 12
|
PRIMARY outcome
Timeframe: Baseline and 24 hours post-infusionMotivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.
Outcome measures
| Measure |
Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)
n=3 Participants
Ketamine 0.41 mg/kg infused over 52 min (K1)
Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg
|
Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)
n=3 Participants
Ketamine 0.71 mg/kg infused over 52 min (K2)
Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings.
|
Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)
n=2 Participants
Lorazepam 2 mg infused over 52 minutes (LZP)
Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control.
|
|---|---|---|---|
|
Change in Motivation to Quit
|
4.35 units on a scale
Interval 2.12 to 6.01
|
3.2 units on a scale
Interval 1.1 to 5.87
|
4.2 units on a scale
Interval 2.12 to 6.56
|
Adverse Events
Ketamine 0.41 (K1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lorazepam 2 mg (LZP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine 0.71 (K2)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place