A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users - INDUCTIO

Phase 1

• Conditions: Opioid dependence; MedDRA version: 9.1Level: LLTClassification code 10013663Term: Drug dependence

• Registration Number: EUCTR2006-005235-14-DE
• Lead Sponsor: Schering-Plough Research Institute - A division of Schering-Plough Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-12
• Study Completion: 2009-12-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must be males or non-pregnant, non-lactating females.
2. Subjects must be at least 18 years of age, of either sex, and any race.
3. Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
4. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(24) for opioid dependence.
5. Subjects must have a methadone- and buprenorphine-negative UDS result
prior to randomization.
6. Each subject must confirm that he or she is practicing adequate contraception. Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or must be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who have been postmenopausal for =1 year (ie, women who have experienced 12 or more consecutive months of amenorrhea) will be exempted from the requirement to use contraception during the study. Acceptable methods include hormonal implants, injectables, combined oral contraceptives, hormonal intrauterine devices and surgical sterilization (eg, hysterectomy or tubal ligation).
7. Female subjects of childbearing potential must have a negative urine beta–
human chorionic gonadotropin (beta-hCG) test prior to enrollment in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects for whom treatment with either Subutex or Suboxone as required in
the protocol would be inconsistent with national labeling.
2. Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
3. Subjects who are participating in any other clinical study in which medication(s) are being delivered.
4. Subjects with known allergy or sensitivity to buprenorphine or naloxone.
5. Subjects who are on the staff, affiliated with, or a family member of the staff
personnel directly involved with this study.
6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
7. HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
8. Methadone or buprenorphine maintenance or detoxification within 30 days of enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified