Trial Outcomes & Findings for Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603) (NCT NCT00723749)

Last Updated: 2012-04-30

Results Overview

The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.

Recruitment status

COMPLETED

Target enrollment

384 participants

Primary outcome timeframe

12 months

Results posted on

2012-04-30

Participant Flow

Recruitment of sites: Jan - Dec 2008 (General Practitioners, Out-Patient-Clinics, Clinics) Recruitment of patients: Mar 2008 - Dec 2009

384 patients were enrolled, 39 datasets were excluded from analysis because 1) physicians withdraw participation agreement, 2) drop-out of patient or final documentation not available

Participant milestones

Participant milestones
Measure	Suboxone Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Study STARTED	345
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	163

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suboxone n=345 Participants Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Age Continuous	35.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants
Sex: Female, Male Male	264 Participants n=5 Participants
Region of Enrollment Germany	345 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).

Outcome measures

Outcome measures
Measure	Suboxone n=345 Participants Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Retention Rate After 12 Months of Treatment With Suboxone	59.9 % of participants Interval 54.9 to 65.1

SECONDARY outcome

Timeframe: Day 1 and Final Assessment (month 12 or time of dropout)

Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.

Outcome measures

Outcome measures
Measure	Suboxone n=345 Participants Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Dosage of SUBOXONE® Dosage: Day 1	9.2 mg daily dosage of Suboxone Standard Deviation 5.1
Dosage of SUBOXONE® Dosage: Final Assessment	7.7 mg daily dosage of Suboxone Standard Deviation 4.4

SECONDARY outcome

Timeframe: Day 1 and Final Assessment (month 12 or time of dropout)

Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment. Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis. A patient can receive only one take home prescription for up to 7 days at the time.

Outcome measures

Outcome measures
Measure	Suboxone n=345 Participants Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Take Home Prescriptions of SUBOXONE® Frequency: Day 1	28 participants with take home prescription
Take Home Prescriptions of SUBOXONE® Frequency: Final Assessment	82 participants with take home prescription

SECONDARY outcome

Timeframe: Baseline and Final Assessment (month 12 or time of dropout)

Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)

Outcome measures

Outcome measures
Measure	Suboxone n=345 Participants Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Drug Craving (Subjective Effects of Therapy) Craving: Baseline	32.3 Units on a scale Standard Deviation 33.1
Drug Craving (Subjective Effects of Therapy) Craving: Final Assessment	7.1 Units on a scale Standard Deviation 17.2

Adverse Events

Suboxone

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Suboxone n=384 participants at risk Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Psychiatric disorders alcohol withdrawal syndrome	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Social circumstances non-compliance	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Surgical and medical procedures planned abortion	1.1% 1/94 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Psychiatric disorders adjustment disorder	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Psychiatric disorders alcohol misuse	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Psychiatric disorders acute psychosis	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Psychiatric disorders medication addiction	0.26% 1/384 • Number of events 4 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Surgical and medical procedures hospitalization	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Nervous system disorders epilepsy	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Injury, poisoning and procedural complications accident at home	0.26% 1/384 • Number of events 1 • from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Director

RB Pharmaceuticals

Phone: +1 (804) 379 1090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Trial results belong to the Sponsor only, all investigators are not allowed to publish trial results without permission of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER