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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Britannia Pharmaceuticals, Ltd. |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00032942 |
Purpose
The purpose of this study is to evaluate lofexidine for opiate withdrawal.
| Condition | Intervention | Phase |
|
Opioid-Related Disorders |
Drug: Lofexidine |
Phase III |
| Drug Information available for: | Lofexidine Lofexidine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal |
| Estimated Enrollment: | 66 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | December 2002 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |||||
| UCLA Medical Center | |||||
| Los Angeles, California, United States, 90095 | |||||
| United States, New York | |||||
| Columbia University | |||||
| New York, New York, United States, 10023 | |||||
| United States, Pennsylvania | |||||
| Philadelphia Veterans Medical Center | |||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| National Institute on Drug Abuse (NIDA) |
| Britannia Pharmaceuticals, Ltd. |
| Principal Investigator: | Ann Montgomery, R.N. | National Institute on Drug Abuse (NIDA) |
More Information
| Responsible Party: | National Institute on Drug about ( Ann Montgomery ) |
| Study ID Numbers: | NIDA-CSP-1020-1 |
| First Received: | April 5, 2002 |
| Last Updated: | July 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00032942 |
| Health Authority: | United States: Food and Drug Administration |
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