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Starting Treatment With Agonist Replacement Therapies (START)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00315341
First received: April 16, 2006
Last updated: October 29, 2009
Last verified: October 2009

April 16, 2006
October 29, 2009
April 2006
June 2010   (final data collection date for primary outcome measure)
Hepatic safety [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Hepatic safety
Complete list of historical versions of study NCT00315341 on ClinicalTrials.gov Archive Site
  • Risk factors [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Risk factors
  • Abstinence
Not Provided
Not Provided
 
Starting Treatment With Agonist Replacement Therapies (START)
Starting Treatment With Agonist Replacement Therapies (START)

The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate-related Disorders
  • 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.
  • 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.
  • Experimental: Buprenorphine/Nx
    Intervention: Drug: Buprenorphine/naloxone
  • Active Comparator: Methadone
    Intervention: Drug: Methadone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1250
June 2010
June 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315341
NIDA-CTN-0027
Yes
Steven Sparenborg, Ph.D., National Institute on Drug Abuse
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
National Institute on Drug Abuse (NIDA)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP