NCT00032955

Brief Summary

The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2001

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

January 12, 2017

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

April 5, 2002

Last Update Submit

January 11, 2017

Conditions

Heroin DependenceMorphine DependenceSubstance Withdrawal Syndrome

Keywords

opiate addictionmorphine addiction

Outcome Measures

Primary Outcomes (6)

  • Drug use

  • Degree of drug craving

  • Adverse events

  • Drug craving

  • Decreased frequency of HIV related behavior

  • Adverse effect measures

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids, and are need of medical assistance for opioid withdrawal.
  • Systolic blood pressure \> or = 100mm Hg, and pulse \> or = 56 bpm.
  • Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians.
  • Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian.
  • Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
  • oral contraceptives
  • barrier (diaphragm or cervical cap) with spermicide or condom
  • intrauterine progesterone contraceptive system
  • levonorgestrel implant
  • medroxyprogesterone acetate contraceptive injection
  • complete abstinence from sexual intercourse

You may not qualify if:

  • Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease);
  • Clinically significant abnormalities in ECG.
  • Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.
  • Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.
  • Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.
  • Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention.
  • Participation in an investigational drug study, including buprenorphine, within the past 30 days.
  • Methadone or LAAM maintenance or detoxification within 30 days of enrollment.
  • Pending legal action that could prohibit or interfere with participation.
  • Unable to remain in area for duration of active phase of treatment.
  • Females that are pregnant, lactating, or planning to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Betty Ford Center

Rancho Mirage, California, 92270, United States

Location

The Center For Drug-Free Living

Orlando, Florida, 32801, United States

Location

Operation PAR, Inc.

Pinellas Park, Florida, 33781, United States

Location

Self Help Addiction Rehabilitation (SHAR), Inc.

Detroit, Michigan, 48208, United States

Location

Phoenix House

New York, New York, 10023, United States

Location

Maryhaven, Inc.

Columbus, Ohio, 43207, United States

Location

Related Links

MeSH Terms

Conditions

Heroin DependenceMorphine DependenceSubstance Withdrawal SyndromeOpioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Walter Ling, M.D.

    Los Angeles Treatment Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

February 1, 2001

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

January 12, 2017

Record last verified: 2010-04

Locations

US(6)