Lofexidine for Opiate Withdrawal - 1
This study has been completed.
Sponsor:
Collaborator:
Britannia Pharmaceuticals Ltd.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032942
First received: April 5, 2002
Last updated: July 21, 2008
Last verified: July 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate lofexidine for opiate withdrawal.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Related Disorders |
Drug: Lofexidine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal |
Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- Opiate withdrawal symptoms
- Potential Abuse Liability
| Estimated Enrollment: | 66 |
| Study Start Date: | April 2001 |
| 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 |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032942
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 | |
Sponsors and Collaborators
Britannia Pharmaceuticals Ltd.
Investigators
| Principal Investigator: | Ann Montgomery, R.N. | National Institute on Drug Abuse (NIDA) |
More Information
No publications provided
| Responsible Party: | Ann Montgomery, National Institute on Drug about |
| ClinicalTrials.gov Identifier: | NCT00032942 History of Changes |
| Obsolete Identifiers: | NCT00007566, NCT00024713 |
| Other Study ID Numbers: | NIDA-CSP-1020-1 |
| Study First Received: | April 5, 2002 |
| Last Updated: | July 21, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Lofexidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Narcotic Antagonists Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013