Trial · NCT00605033

A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

NCT00605033, Phase 4, Completed, Indivior Inc.; results first posted 2010-06-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED). Trials, record NCT00605033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605033

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
NCT number: NCT00605033
Status: Completed
Phases: Phase 4
Enrollment: 241 participants, actual
Lead sponsor: Indivior Inc.
Conditions: Opiate Dependence, Drug Dependence
Interventions: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
First posted: 2008-01-30
Last updated: 2016-10-21
Results first posted: 2010-06-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate	Assessed by Day 7 of double-blind, double-dummy treatment period.	Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate	Assessed by Day 7 of double-blind, double-dummy treatment period.	Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Response Rate	Suboxone		83.2		Percentage of participants
Response Rate	Subutex		88.7		Percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Suboxone	143
Overall Study	STARTED	Subutex	98
Overall Study	COMPLETED	Suboxone	136
Overall Study	COMPLETED	Subutex	90
Overall Study	NOT COMPLETED	Suboxone	7
Overall Study	NOT COMPLETED	Subutex	8

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Lacrimation increased	Eye disorders	Suboxone	9	143	9
other	Lacrimation increased	Eye disorders	Subutex	1	97	1
other	Abdominal pain upper	Gastrointestinal disorders	Suboxone	9	143	14
other	Abdominal pain upper	Gastrointestinal disorders	Subutex	4	97	5
other	Diarrhoea	Gastrointestinal disorders	Suboxone	8	143	8
other	Diarrhoea	Gastrointestinal disorders	Subutex	1	97	1
other	Nausea	Gastrointestinal disorders	Suboxone	21	143	29
other	Nausea	Gastrointestinal disorders	Subutex	7	97	8
other	Toothache	Gastrointestinal disorders	Suboxone	1	143	1
other	Toothache	Gastrointestinal disorders	Subutex	5	97	5

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Suboxone
Total, all-cause mortality	Subutex
Total, other adverse events	Suboxone	79	143
Total, other adverse events	Subutex	52	97
Total, serious adverse events	Suboxone	2	143
Total, serious adverse events	Subutex	4	97

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Suboxone vs Subutex: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00605033

GET https://conductscience.org/api/trials/v1/NCT00605033/events?page=2

API reference For AI assistants