Lofexidine for Opiate Withdrawal - 1

NCT ID: NCT00032942

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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The purpose of this study is to evaluate lofexidine for opiate withdrawal.

Detailed Description

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An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lofexidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male or female as least 18 yrs of age \& above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

Exclusion Criteria

Additional criteria available during screening at the site
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Britannia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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National Institute on Drug about

Principal Investigators

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Ann Montgomery, R.N.

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Philadelphia Veterans Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CSP-1020-1

Identifier Type: -

Identifier Source: org_study_id

NCT00007566

Identifier Type: -

Identifier Source: nct_alias

NCT00024713

Identifier Type: -

Identifier Source: nct_alias

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