N/A N=345

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

Opioid-Related Disorders · Opiate Dependence · Drug Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00723749 ↗

Enrolled (actual)

345

Serious AEs

2.6%

Results posted

Apr 2012

Primary outcome: Primary: Retention Rate After 12 Months of Treatment With Suboxone — 59.9 % of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Buprenorphine/Naloxone (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Indivior Inc.
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention Rate After 12 Months of Treatment With Suboxone	59.9	—
SECONDARY Dosage of SUBOXONE®	9.2; 7.7	—
SECONDARY Take Home Prescriptions of SUBOXONE®	28; 82	—
SECONDARY Drug Craving (Subjective Effects of Therapy)	32.3; 7.1	—

Summary

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Eligibility Criteria

Inclusion Criteria

Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria

In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00723749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.