Trial · NCT00315341

Starting Treatment With Agonist Replacement Therapies (START)

NCT00315341, Phase 4, Completed, University of California, Los Angeles; results first posted 2017-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Starting Treatment With Agonist Replacement Therapies (START). Trials, record NCT00315341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00315341

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Trial

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

Title: Starting Treatment With Agonist Replacement Therapies (START)
NCT number: NCT00315341
Status: Completed
Phases: Phase 4
Enrollment: 1,269 participants, actual
Lead sponsor: University of California, Los Angeles
Conditions: Opiate-related Disorders
Interventions: Buprenorphine/naloxone, Methadone
First posted: 2006-04-18
Last updated: 2017-01-06
Results first posted: 2017-01-06

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Hepatic Safety	24 Weeks	Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner: A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN C: Either ALT or AST started \> 2 x ULN, decreased (both ALT and AST) to \< 2 x ULN, and remained \< 2 x ULN D: Either ALT or AST started \> 2 x ULN and remained above 2 x ULN throughout the study

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	Hepatic Safety	24 Weeks	evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Units
Hepatic Safety	Buprenorphine/Nx	ALT - A (low, stays low)	278	participants
Hepatic Safety	Methadone	ALT - A (low, stays low)	318	participants
Hepatic Safety	Buprenorphine/Nx	ALT - B (low, goes high)	41	participants
Hepatic Safety	Methadone	ALT - B (low, goes high)	62	participants
Hepatic Safety	Buprenorphine/Nx	ALT - C (high, goes low, stays low)	4	participants
Hepatic Safety	Methadone	ALT - C (high, goes low, stays low)	1	participants
Hepatic Safety	Buprenorphine/Nx	ALT - D (high, stays high)	17	participants
Hepatic Safety	Methadone	ALT - D (high, stays high)	10	participants
Hepatic Safety	Buprenorphine/Nx	AST - A (low, stay low)	291	participants
Hepatic Safety	Methadone	AST - A (low, stay low)	328	participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Buprenorphine/Nx	740
Overall Study	STARTED	Methadone	529
Overall Study	COMPLETED	Buprenorphine/Nx	340
Overall Study	COMPLETED	Methadone	391
Overall Study	NOT COMPLETED	Buprenorphine/Nx	400
Overall Study	NOT COMPLETED	Methadone	138

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	alanine aminotransferase increased	Investigations	Buprenorphine/Nx	81	727	104
other	alanine aminotransferase increased	Investigations	Methadone	70	520	94
other	aspartate aminotransferase increased	Investigations	Buprenorphine/Nx	70	727	78
other	aspartate aminotransferase increased	Investigations	Methadone	63	520	87
other	gamma glutamyltransferase increased	Investigations	Buprenorphine/Nx	47	727	54
other	gamma glutamyltransferase increased	Investigations	Methadone	57	520	71
other	weight increased	Investigations	Buprenorphine/Nx	10	727	10
other	weight increased	Investigations	Methadone	26	520	26
other	nasopharyngitis	Infections and infestations	Buprenorphine/Nx	119	727	147
other	nasopharyngitis	Infections and infestations	Methadone	117	520	165

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	Buprenorphine/Nx
Total, all-cause mortality	Methadone
Total, other adverse events	Buprenorphine/Nx	530	727
Total, other adverse events	Methadone	442	520
Total, serious adverse events	Buprenorphine/Nx	38	727
Total, serious adverse events	Methadone	45	520

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22921476	RESULT	PubMed
23961726	DERIVED	PubMed
24751432	DERIVED	PubMed
29333880	DERIVED	PubMed
34328394	DERIVED	PubMed
36063082	DERIVED	PubMed
36655851	DERIVED	PubMed
38616571	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10DA013045	The National Drug Abuse Treatment Clinical Trials Network	LING, WALTER NMN	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE ON DRUG ABUSE	1999 to 2015

Source NIH RePORTER

Trial comparisons1

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

Comparison
Buprenorphine/Nx vs Methadone: 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/NCT00315341

GET https://conductscience.org/api/trials/v1/NCT00315341/events?page=2

API reference For AI assistants