NCT00723697

Brief Summary

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 10, 2011

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

July 25, 2008

Results QC Date

April 14, 2011

Last Update Submit

March 16, 2023

Conditions

BuprenorphineNaloxoneOpiate-related DisordersOpiate DependenceDrug Abuse

Keywords

Subutex

Outcome Measures

Primary Outcomes (2)

  • Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)

    Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

    first visit, 6 months, and 12 months

  • Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.

    Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

    first visit, 6 months, and 12 months

Secondary Outcomes (1)

  • Number of Patients Reporting Clinical Consequences of Engaging in Misuse

    first visit, 6 months, and 12 months

Study Arms (1)

Patients

Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.

Drug: buprenorphine

Interventions

buprenorphineDRUG

0.4, 2, or 8 mg sublingual tablets

Also known as: Subutex, buprenorphine high dose (BHD) generic (Arrow Laboratories), SCH 028444
Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)

You may qualify if:

  • Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.
  • The patient must have been informed orally and in writing via the information notice and have signed it.

You may not qualify if:

  • Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

BuprenorphineDrugs, Generic

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPharmaceutical Preparations

Results Point of Contact

Title
Vice President of Late Stage Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

May 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 20, 2023

Results First Posted

May 10, 2011

Record last verified: 2023-03