Lofexidine for Inpatient Opiate Detox

This study has been completed.
Sponsor:
Collaborators:
US WorldMeds LLC
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00235729
First received: October 6, 2005
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

The main objective of this study is to investigate the effectiveness of lofexidine in reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently, lofexidine is the most commonly used non-opiate medication for detoxification from opiates in the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug Administration (FDA) for the same indication in the United States (US). The only medications currently approved by the FDA for opiate detoxification are methadone and buprenorphine. These medications, however, have the potential to be abused. Lofexidine, on the other hand, offers a unique advantage for opiate detoxification because it is not addicting, is easy to use, and has a favorable safety profile.


Condition Intervention Phase
Opiate Addiction
Drug: Lofexidine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: CSP #1024 - A Phase III, Randomized, Multi-Center, Double Blind, Placebo-Controlled Study of Safety and Efficacy of Lofexidine for Relief of Symptoms in Subjects Undergoing Inpatient Opiate Detoxification.

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • SOWS-Gossop score on Day 3 during the treatment phase & time-to-dropout for the subjects in the two treatment groups. during the treatment phase. [ Time Frame: Day 3 of treatment phase for the SOWs score. Time to dropout will be measured as the number of 6-hour time quadrants until a subject withdraws or completes the treatment phase of the study ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: June 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lofexidine 0.8 mg QID
Drug: Lofexidine
Lofexidine is an alpha2-adrenergic-agonist with mild to moderate antihypertensive actions. It is mainly used in the alleviation of opioid withdrawal signs and symptoms.
Placebo Comparator: 2
Placebo QID
Drug: Placebo
Placebo is an exact match of lofexidine, less the active ingredient.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Potential subjects must:

  1. Be at least 18 years of age.
  2. Have current dependence, according to SCID criteria, on any opioid with a half-life similar to heroin or morphine, including Vicodin, Lortab, or Lorcet, Percocet, Percodan, Tylox, or Hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected or swallowed after chewing).
  3. Be seeking treatment for opiate dependence.
  4. Have a score greater than or equal to 2 on the Objective Opiate Withdrawal Scale-Handelsman (OOWS) immediately prior to admission.
  5. Have reported use of heroin, morphine, or any opioid with a half-life similar to heroin or morphine, for at least 21 of the past 30 days.
  6. Have urine toxicology screen positive for opiates and negative for methadone or buprenorphine.
  7. If female and of child bearing potential, agree to use of one of the following methods of birth control:

    1. oral contraceptives
    2. patch
    3. barrier (diaphragm, sponge or condom) plus spermicidal preparations
    4. intrauterine contraceptive system
    5. levonorgestrel implant
    6. medroxyprogesterone acetate contraceptive injection
    7. complete abstinence from sexual intercourse
    8. hormonal vaginal contraceptive ring
    9. surgical sterilization or partner sterile (must have documented proof)
  8. Have completed the ASI during screening and all other assessments (SOWS-Gossop OOWS, and MCGI) during the baseline period.
  9. Be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures and pass the study consent quiz with 100% accuracy (if necessary, quiz may be administered more than one time).

Exclusion Criteria:

Potential subjects must not:

  1. Be female subjects who are pregnant or lactating.
  2. Have self-reported use of methadone or buprenorphine in the past 14 days.
  3. Have serious medical illnesses including, but not limited to:

    1. Seizures, or those who have received anticonvulsant therapy during the past 5 years.
    2. Pancreatic disease such as insulin-dependent diabetes.
    3. Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 5 times the upper limit of normal.
    4. Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment.
  4. Have a psychiatric disorder, as assessed by the SCID, including but not limited to dementia or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult.
  5. Have self-reported AIDS.
  6. Have an abnormal cardiovascular exam prior to randomization, including any of the following:

    1. Clinically significant abnormal ECG (e.g., second or third degree heart block, uncontrolled arrhythmia, or QTc interval > 450 msec for males, and > 470 msec for females).
    2. Heart rate less than 45 bpm or symptomatic bradycardia.
    3. Systolic blood pressure < 90 mm Hg or symptomatic hypotension (diastolic blood pressure < 60 mm Hg).
    4. Blood pressure > 160/100 mm Hg.
    5. Prior history of myocardial infarction.
  7. Have clinically significant abnormal laboratory values.
  8. Require any of the following medications currently or within the past 4 weeks: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics (excluding those listed in inclusion criteria #2 above), anticonvulsants, antihypertensives, antiarrhythmics, antiretroviral, and cholesterol lowering medications. Nicotine replacement therapy (patch, inhaler, gum, or nasal spray) for nicotine-dependent subjects are allowed.
  9. Have current dependence (by SCID criteria) on
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235729

Locations
United States, California
CNS, Cerritos
Cerritos, California, United States, 90703
United States, District of Columbia
CNS Psychiatric Institute of Washington
Washington, District of Columbia, United States, 20016
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Alexian Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60194
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48207
United States, New York
Richmond Medical Center
Staten Island, New York, United States, 10304
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
United States, Tennessee
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232-8650
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
Aurora Psychiatric Hospital
Wauwatosa, Wisconsin, United States, 53213
Sponsors and Collaborators
US WorldMeds LLC
Investigators
Study Chair: Charles W. Gorodetzky VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Gorodetzky, Charles - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00235729     History of Changes
Other Study ID Numbers: 1024, USWM-001
Study First Received: October 6, 2005
Last Updated: March 19, 2009
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Opiate addiction
Opiate dependence
Withdrawal symptoms

Additional relevant MeSH terms:
Lofexidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014