Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

NCT00142909 | Completed Phase 2 Results DMC

• 3 other identifiers: NIDA-18219-1R01-18219-1DPMC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to determine whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress and subsequently increase the chances of remaining abstinent from opiates.

Conditions

Opioid-Related Disorders

Keywords

Opioid dependence

Outcome Measures

Primary Outcomes (2)

• SOWS: the Subjective Opiate Withdrawal Scale

  The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/

  1 Week

• SOWS: the Subjective Opiate Withdrawal Scale

  The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/

  12 weeks

Secondary Outcomes (4)

• Systolic Blood Pressure

  1 Week

• Systolic Blood Pressure

  12 weeks

• Diastolic Blood Pressure

  1 Week

• Diastolic Blood Pressure

  12 weeks

Study Arms (2)

Drug: Lofexidine

EXPERIMENTAL

Lofexidine: Study medication Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.

Drug: Lofexidine

Drug: Placebo

PLACEBO COMPARATOR

Placebo pill. Participants will receive daily placebo and will follow the same scheduled delivery as those in the intervention for 12 weeks.

Drug: Placebo

Interventions

Lofexidine DRUG

Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.

Drug: Lofexidine

Placebo DRUG

Lofexidine Placebo

Drug: Placebo

Eligibility Criteria

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

You may qualify if:

• Meets DSM-IV criteria for opioid dependence
• Eligible to take a daily dose of 50 mg of naltrexone
• Normal EKG
• Able to read English

You may not qualify if:

• Currently psychotic or psychiatrically disabled (e.g., suicidal, homicidal, manic)
• Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, antihypertensives (including clonidine), antiarrhythmics, antiretroviral medications, or tricyclic antidepressants
• Underlying medical conditions, such as cerebral, kidney, thyroid, or cardiac pathology, and currently taking medications for any of these conditions
• Abstinent from opiates for more than 4 weeks prior to initiation of naltrexone
• Medical problems precluding naltrexone treatment, such as hepato-cellular injury, as evidenced by abnormal liver enzyme tests (greater than three times the normal level) and a history of cirrhosis
• Hypotensive (resting blood pressure below 90/50 mm Hg)
• Pregnant or breastfeeding
• Use of an investigational drug within the 3 months prior to enrollment

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University, Psychiatry

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

lofexidine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rajita Sinha, Ph.D
• Organization: Yale University School of Medicine

rajita.sinha@yale.edu

203-737-5805

Study Officials

• Rajita Sinha

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: February 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 30, 2015
• Results First Posted: November 20, 2013

Record last verified: 2015-07

Locations

US (1)