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Starting Treatment With Agonist Replacement Therapies (START)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
University of California, Los Angeles
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 16, 2006
Last updated: October 29, 2009
Last verified: October 2009
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.

Condition Intervention Phase
Opiate-related Disorders
Drug: Buprenorphine/naloxone
Drug: Methadone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Starting Treatment With Agonist Replacement Therapies (START)

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Hepatic safety [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Risk factors [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1250
Study Start Date: April 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine/Nx Drug: Buprenorphine/naloxone
Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.
Active Comparator: Methadone Drug: Methadone
Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.

Detailed Description:
This is a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization will be stratified, within site, according to normal versus abnormal screening liver function tests. Participants meeting entry criteria will be dosed for 24 weeks during the active phase of the study with assessment of liver function at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. Clinicians will be encouraged to treat with adequate doses of BUP/NX and MET.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • Meet DSM-IV criteria for opioid dependence
  • In good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, be under the care of a physician willing to continue subject's medical management and cooperate with study physicians
  • Have blood chemistry values normal for: creatinine, direct bilirubin, albumin, and prothrombin time (INR) as per the criteria of the laboratory
  • Able to read and verbalize understanding and voluntarily sign the approved Informed Consent form prior to performance of any study-specific procedures.

Exclusion Criteria:

  • ALP, AST or ALT values greater than 5 times the upper limit of normal as per the criteria of the contracted central laboratory
  • Ascites, GI bleeding, or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of 11 or greater
  • Acute medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., unstable pancreatic, cardiovascular or renal disease, significant anemia)
  • Known allergy or sensitivity to BUP, naloxone or MET or to any of the inactive ingredients in the study medications (including lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, Acesulfame K sweetener)
  • Known diagnosis of acute psychosis, severe depression or imminent suicide risk as determined via clinical interview by study physician or surrogates
  • Dependence on alcohol, benzodiazepines (dependent on clinician's judgment regarding need for immediate medical attention and likelihood of intravenous misuse) or other depressants, or stimulants that requires immediate medical attention
  • Participation in an investigational drug study within the past 30 days
  • Treatment with MET, BUP/NX, or BUP within the past 30 days (illicit use of these medications is allowed)
  • Pending legal action that could prohibit study participation
  • Unable or unwilling to comply with study requirements
  • Unable or unwilling to remain in the local area for duration of treatment
  • Poor venous access such that venipuncture could not be accomplished from a vein in an extremity during screening
  • Pregnant or lactating (females only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00315341

United States, California
Matrix Institute
Los Angeles, California, United States, 90016
Bi-Valley Medical Clinic INC.
Sacramento, California, United States, 95816
BAART; Turk Street Clinic
San Francisco, California, United States, 94102
United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
CT Counseling Centers
Waterbury, Connecticut, United States, 06705
United States, New York
Addiction Research & Treatment Corp
Brooklyn, New York, United States, 11201
United States, Oregon
Portland, Oregon, United States, 97214
United States, Pennsylvania
NET Steps
Philadelphia, Pennsylvania, United States, 19137
United States, Washington
Evergreen Treatment Services
Seattle, Washington, United States, 98134
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
Principal Investigator: Walter Ling, M.D. University of California, Los Angeles
Principal Investigator: Andrew Saxon, M.D. University of Washington
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven Sparenborg, Ph.D., National Institute on Drug Abuse Identifier: NCT00315341     History of Changes
Other Study ID Numbers: NIDA-CTN-0027 
Study First Received: April 16, 2006
Last Updated: October 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents processed this record on December 06, 2016