Title
Lofexidine for Opiate Withdrawal - 1
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Phase
Phase 3Lead Sponsor
National Institute on Drug Abuse (NIDA)Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Opioid-Related DisordersIntervention/Treatment
lofexidine ...Study Participants
66The purpose of this study is to evaluate lofexidine for opiate withdrawal.
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.
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