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Lofexidine for Opiate Withdrawal - 1

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 3

Conditions

Opioid-Related Disorders

Treatments

Drug: Lofexidine

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00032942
NIDA-CSP-1020-1

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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