Starting Treatment With Agonist Replacement Therapies (START)

Opiate-related Disorders Clinical Trial

Official title:

Starting Treatment With Agonist Replacement Therapies (START)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00315341
• Other study ID #: NIDA-CTN-0027
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 16, 2006
• Last updated: October 29, 2009
• Start date: April 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1250
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate-related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Addiction Research & Treatment Corp	Brooklyn	New York
United States	Hartford Dispensary	Hartford	Connecticut
United States	Matrix Institute	Los Angeles	California
United States	NET Steps	Philadelphia	Pennsylvania
United States	CODA-Research	Portland	Oregon
United States	Bi-Valley Medical Clinic INC.	Sacramento	California
United States	BAART; Turk Street Clinic	San Francisco	California
United States	Evergreen Treatment Services	Seattle	Washington
United States	CT Counseling Centers	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic safety		24 Weeks	Yes
Secondary	Risk factors		24 Weeks	Yes
Secondary	Abstinence		6 months	No