Lofexidine for Opiate Withdrawal - 1
Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00032942
Collaborator
Britannia Pharmaceuticals Ltd. (Industry)
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3
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Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate lofexidine for opiate withdrawal.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed 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.
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Study Start Date
:
Apr 1, 2001
Actual Primary Completion Date
:
Oct 1, 2004
Outcome Measures
Primary Outcome Measures
- Opiate withdrawal symptoms []
- Potential Abuse Liability []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 2 | Columbia University | New York | New York | United States | 10023 |
| 3 | Philadelphia Veterans Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- National Institute on Drug Abuse (NIDA)
- Britannia Pharmaceuticals Ltd.
Investigators
- Principal Investigator: Ann Montgomery, R.N., National Institute on Drug Abuse (NIDA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00032942
Other Study ID Numbers:
- NIDA-CSP-1020-1
- NCT00007566
- NCT00024713
First Posted:
Apr 8, 2002
Last Update Posted:
Jan 12, 2017
Last Verified:
Jul 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: