Lofexidine for Inpatient Opiate Detox

NCT00235729 | Completed Phase 3 DMC

• 2 other identifiers: 1024USWM-001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Opiate Addiction

Keywords

Opiate addiction; Opiate dependence; Withdrawal symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

1

EXPERIMENTAL

Lofexidine 0.8 mg QID

Drug: Lofexidine

2

PLACEBO COMPARATOR

Placebo QID

Drug: Placebo

Interventions

Lofexidine DRUG

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.

1

Placebo DRUG

Placebo is an exact match of lofexidine, less the active ingredient.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must:
• Be at least 18 years of age.
• 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).
• Be seeking treatment for opiate dependence.
• Have a score greater than or equal to 2 on the Objective Opiate Withdrawal Scale-Handelsman (OOWS) immediately prior to admission.
• 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.
• Have urine toxicology screen positive for opiates and negative for methadone or buprenorphine.
• If female and of child bearing potential, agree to use of one of the following methods of birth control:
• oral contraceptives
• patch
• barrier (diaphragm, sponge or condom) plus spermicidal preparations
• intrauterine contraceptive system
• levonorgestrel implant
• medroxyprogesterone acetate contraceptive injection
• complete abstinence from sexual intercourse

You may not qualify if:

• Potential subjects must not:
• Be female subjects who are pregnant or lactating.
• Have self-reported use of methadone or buprenorphine in the past 14 days.
• Have serious medical illnesses including, but not limited to:
• Seizures, or those who have received anticonvulsant therapy during the past 5 years.
• Pancreatic disease such as insulin-dependent diabetes.
• Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 5 times the upper limit of normal.
• Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment.
• 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.
• Have self-reported AIDS.
• Have an abnormal cardiovascular exam prior to randomization, including any of the following:
• 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).
• Heart rate less than 45 bpm or symptomatic bradycardia.
• Systolic blood pressure \< 90 mm Hg or symptomatic hypotension (diastolic blood pressure \< 60 mm Hg).
• Blood pressure \> 160/100 mm Hg.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• National Institute on Drug Abuse (NIDA): collaborator
• USWM, LLC (dba US WorldMeds): collaborator

Study Sites (16)

CNS, Cerritos

Cerritos, California, 90703, United States

Location

CNS Psychiatric Institute of Washington

Washington D.C., District of Columbia, 20016, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Alexian Center for Psychiatric Research

Hoffman Estates, Illinois, 60194, United States

Location

University of Kentucky

Lexington, Kentucky, 40502, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48207, United States

Location

Richmond Medical Center

Staten Island, New York, 10304, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37232-8650, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Aurora Psychiatric Hospital

Wauwatosa, Wisconsin, 53213, United States

Location

Related Publications (1)

• Alam D, Tirado C, Pirner M, Clinch T. Efficacy of lofexidine for mitigating opioid withdrawal symptoms: results from two randomized, placebo-controlled trials. J Drug Assess. 2020 Jan 8;9(1):13-19. doi: 10.1080/21556660.2019.1704416. eCollection 2020.

  PMID: 32002194 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance Withdrawal Syndrome

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Charles W. Gorodetzky

  VA Maryland Health Care System, Baltimore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: June 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

US (16)