Trial Outcomes & Findings for Prescription Opioid Effects in Abusers Versus Non-Abusers (NCT NCT00158184)

Results Overview

Maximum number of finger presses on a computer mouse completed. The "Breakpoint" is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session

Results posted on

2017-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Rx Opioid Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.	Rx Opioid Non-Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.
Overall Study STARTED	16	11
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rx Opioid Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.	Rx Opioid Non-Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.
Overall Study personal issues	3	1
Overall Study failed for follow unit/study rules	2	0
Overall Study Adverse Event	1	1

Baseline Characteristics

Prescription Opioid Effects in Abusers Versus Non-Abusers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rx Opioid Abusers n=16 Participants Prescription Opioids users with abusive patterns of use.	Rx Opioid Medical Users n=11 Participants Prescription Opioids users without abusive patterns of use.	Total n=27 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 8 • n=93 Participants	28 years STANDARD_DEVIATION 6 • n=4 Participants	30 years STANDARD_DEVIATION 7 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	7 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	11 participants n=4 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session

Maximum number of finger presses on a computer mouse completed. The "Breakpoint" is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability.

Outcome measures

Outcome measures
Measure	Rx Opioid Abusers n=10 Participants Recreational prescription opioid users.	Rx Opioid Non-Abusers n=9 Participants Medical prescription opioid users.
Breakpoint Placebo: 0 mg	25 Mouse Clicks Standard Error 20	400 Mouse Clicks Standard Error 200
Breakpoint Oxycodone: 15mg	1400 Mouse Clicks Standard Error 400	850 Mouse Clicks Standard Error 100
Breakpoint Oxycodone: 30mg	1100 Mouse Clicks Standard Error 350	900 Mouse Clicks Standard Error 160

SECONDARY outcome

Timeframe: Highest rating obtained following adminstration of each of the 3 test doses.

Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."

Outcome measures

Outcome measures
Measure	Rx Opioid Abusers n=10 Participants Recreational prescription opioid users.	Rx Opioid Non-Abusers n=9 Participants Medical prescription opioid users.
Drug Liking Oxycodone: 15 mg	60 units on a scale Standard Error 7	53 units on a scale Standard Error 8
Drug Liking Placebo: 0 mg	23 units on a scale Standard Error 5	21 units on a scale Standard Error 7
Drug Liking Oxycodone: 30 mg	59 units on a scale Standard Error 8	40 units on a scale Standard Error 9

Adverse Events

Rx Opioid Abusers

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Rx Opioid Non-Abusers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rx Opioid Abusers n=16 participants at risk	Rx Opioid Non-Abusers n=11 participants at risk
Gastrointestinal disorders Nausea	12.5% 2/16 • Number of events 2 • Averse events were assessed daily from the date of admission until the date of discharge. Participants also returned for a 30-Day follow-up after being discharged, during which adverse events were assessed. Adverse events are classified as serious or non-serious.	0.00% 0/11 • Averse events were assessed daily from the date of admission until the date of discharge. Participants also returned for a 30-Day follow-up after being discharged, during which adverse events were assessed. Adverse events are classified as serious or non-serious.

Additional Information

Dr. Sandra D. Comer

Substance Use Research Center

Phone: 212-543-5981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place