MedDataX Logo

Trial Outcomes & Findings for Hyperalgesia in Methadone-Maintained Patients: Can it be Treated? (NCT NCT01210079)

NCT ID: NCT01210079

Last Updated: 2012-04-06

Results Overview

Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

baseline, 5 weeks

Results posted on

2012-04-06

Participant Flow

Participant milestones

Participant milestones
Measure
Gabapentin
Gabapentin titrated to 2400 mg daily PO for 5 weeks
Placebo
Matched placebo group underwent identical 'titration' as intervention group.
Overall Study
STARTED
10
16
Overall Study
COMPLETED
10
16
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Gabapentin
n=10 Participants
Gabapentin titrated to 2400 mg daily PO for 5 weeks
Placebo
n=16 Participants
Matched placebo group underwent identical 'titration' as intervention group.
Total
n=26 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=93 Participants
16 Participants
n=4 Participants
26 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age Continuous
45.5 years
STANDARD_DEVIATION 4.46 • n=93 Participants
49.5 years
STANDARD_DEVIATION 4.96 • n=4 Participants
47.9 years
STANDARD_DEVIATION 5.05 • n=27 Participants
Sex: Female, Male
Female
5 Participants
n=93 Participants
7 Participants
n=4 Participants
12 Participants
n=27 Participants
Sex: Female, Male
Male
5 Participants
n=93 Participants
9 Participants
n=4 Participants
14 Participants
n=27 Participants
Region of Enrollment
United States
10 participants
n=93 Participants
16 participants
n=4 Participants
26 participants
n=27 Participants

PRIMARY outcome

Timeframe: baseline, 5 weeks

Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.

Outcome measures

Outcome measures
Measure
Gabapentin
n=10 Participants
Gabapentin titrated to 2400 mg daily PO for 5 weeks
Placebo
n=16 Participants
Matched placebo group underwent identical 'titration' as intervention group.
Change in Pain Threshold Time From Baseline to Week 5
2.95 seconds
Standard Error 2.41
-3.49 seconds
Standard Error 2.85

Adverse Events

Gabapentin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

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

Margaret (Peggy) Compton, RN PhD

School of Nursing, University of California, Los Angeles

Phone: (310) 206-2825

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place