Trial Outcomes & Findings for Abuse Liability of Suboxone Versus Subutex (NCT NCT00710385)

NCT ID: NCT00710385

Last Updated: 2016-12-05

Results Overview

Measure of a drug's reinforcing effects. The "Breakpoint" is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 19 participants
• Primary outcome timeframe: Single measurement taken following each of the 7 IV experimental doses
• Results posted on: 2016-12-05

Participant Flow

Enrollment dates: September 10, 2007 - August 13, 2008 Location: Medical clinic

Participant milestones

Measure	Intravenous Challenge Doses This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Intravenous Challenge Doses This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
Overall Study Did not qualify	1
Overall Study Withdrawal by Subject	1
Overall Study Undisclosed back pain	1
Overall Study Physician Decision	1
Overall Study Undisclosed excessive methadone use	1

Baseline Characteristics

Abuse Liability of Suboxone Versus Subutex

Baseline characteristics by cohort

Measure	Challenge Doses n=12 Participants This study employs a within-subjects design, all participant experience all challenge doses.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36.2 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Single measurement taken following each of the 7 IV experimental doses

Population: Heroin users, not seeking treatment

Measure of a drug's reinforcing effects. The "Breakpoint" is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested

Outcome measures

Measure	Heroin n=12 Participants Intravenous heroin 25 mg	Naloxone n=12 Participants Intravenous Naloxone HCl	Low Bup Dose n=12 Participants Lower doses of intravenous buprenorphine alone.	High Bup Dose n=12 Participants Higher doses of intravenous buprenorphine	Lower Bup/Nal Dose n=12 Participants Lower doses of intravenous buprenorphine + naloxone.	High Bup/Nal Dose n=12 Participants Higher doses of intravenous buprenorphine +naloxone	Placebo n=12 Participants Control intravenous placebo drug administration.
Drug's Breakpoint	1200 number of clicks on a mouse Standard Deviation 200	10 number of clicks on a mouse Standard Deviation 10	1100 number of clicks on a mouse Standard Deviation 180	1200 number of clicks on a mouse Standard Deviation 190	300 number of clicks on a mouse Standard Deviation 100	750 number of clicks on a mouse Standard Deviation 175	0 number of clicks on a mouse Standard Deviation 0

SECONDARY outcome

Timeframe: Peak (highest) rating obtained following drug administration throughout the entire 3 hr session

Participant's subjective ratings of how much they "Like" the dose they just received on a scale of 0 -100.

Outcome measures

Measure	Heroin n=12 Participants Intravenous heroin 25 mg	Naloxone n=12 Participants Intravenous Naloxone HCl	Low Bup Dose n=12 Participants Lower doses of intravenous buprenorphine alone.	High Bup Dose n=12 Participants Higher doses of intravenous buprenorphine	Lower Bup/Nal Dose n=12 Participants Lower doses of intravenous buprenorphine + naloxone.	High Bup/Nal Dose n=12 Participants Higher doses of intravenous buprenorphine +naloxone	Placebo n=12 Participants Control intravenous placebo drug administration.
Drug "Liking"	41.5 units on a scale Standard Error 5	3 units on a scale Standard Error 2.7	29.8 units on a scale Standard Error 4	42.5 units on a scale Standard Error 5	10.5 units on a scale Standard Error 2.4	27 units on a scale Standard Error 4	1 units on a scale Standard Error .6

Adverse Events

Combined for All Study Conditions

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Combined for All Study Conditions n=17 participants at risk This study employed a within-subjects design, all participants experienced all study conditions.
Skin and subcutaneous tissue disorders urticaria	11.8% 2/17 • Number of events 2 • Adverse events were assessed for daily throughout the study. An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
Gastrointestinal disorders vomiting	5.9% 1/17 • Number of events 1 • Adverse events were assessed for daily throughout the study. An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
Injury, poisoning and procedural complications dizziness	5.9% 1/17 • Number of events 1 • Adverse events were assessed for daily throughout the study. An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
Injury, poisoning and procedural complications chest discomfort	5.9% 1/17 • Number of events 1 • Adverse events were assessed for daily throughout the study. An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
Injury, poisoning and procedural complications Mild Opioid Withdrawal	17.6% 3/17 • Number of events 3 • Adverse events were assessed for daily throughout the study. An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.

Additional Information

Sandra D. Comer

Substance Abuse

Phone: 646-774-6146

Email: sdc10@columbia.edu

Results disclosure agreements

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