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Alpha-2 Adrenergic Agonist

Lofexidine for Opioid Addiction

Phase 2

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments

Age 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following social stress and scripted imagery tasks

Awards & highlights

Study Summary

This trial will test whether lofexidine, a medication used to treat high blood pressure, can help reduce stress, craving, and use in people with opioid use disorder.

Who is the study for?

Adults aged 18-65 with opioid use disorder, primarily using opioids and on a stable dose of buprenorphine or methadone for at least two weeks. They must not have severe substance use disorders (except tobacco, caffeine, or marijuana) in the last 60 days and agree to birth control if applicable.Check my eligibility

What is being tested?

The trial is testing whether lofexidine helps reduce stress, cravings, and opioid use compared to a placebo over five weeks in individuals stabilized on buprenorphine or methadone. Participants will also complete tasks assessing their response to stress and drug cues.See study design

What are the potential side effects?

Lofexidine may cause low blood pressure, slow heart rate, dizziness, dry mouth, sleep disturbance. It can potentially increase heart rhythm interval (QTc), which could be risky when combined with other medications like buprenorphine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and agree to the study's requirements.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following social stress and scripted imagery tasks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following social stress and scripted imagery tasks

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following social stress and scripted imagery tasks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Drug Cue+ Stressor Induced Craving

Drug Cue+ Stressor Induced Stress Response

Side effects data

From 2014 Phase 2 & 3 trial • 156 Patients • NCT01020019

44%

dry mouth

43%

fatigue

34%

dizzy

21%

intoxication

21%

insomnia

16%

hypotension

16%

headache

15%

drowsiness

10%

nausea

sweating

orthostasis

gas

confusion

anxiety

irritability

depression

upper respiratory infection

sore throat

decreased appetite

diarrhea

vomitting

stomache upset

fever

abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Lofexidine and Dronabinol

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Lofexidine WomenExperimental Treatment1 Intervention

Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.

Group II: Lofexidine MenExperimental Treatment1 Intervention

Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.

Group III: Placebo MenPlacebo Group1 Intervention

Men will receive matching placebo for five weeks.

Group IV: Placebo WomenPlacebo Group1 Intervention

Women will receive matching placebo for five weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lofexidine

2010

Completed Phase 4

~1100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,278 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,468 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,467 Previous Clinical Trials

2,619,011 Total Patients Enrolled

Media Library

Lofexidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03718065 — Phase 2

Opioid Use Disorder Research Study Groups: Lofexidine Men, Lofexidine Women, Placebo Men, Placebo Women

Opioid Use Disorder Clinical Trial 2023: Lofexidine Highlights & Side Effects. Trial Name: NCT03718065 — Phase 2

Lofexidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718065 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Lofexidine been trialed before as a medication?

"Currently, 5 research studies are underway to investigate lofexidine. 1 of those trials has reached Phase 3 status. The majority of the clinical sites for these investigations are located in Baltimore, Maryland; however, there are a total of 7 locations running these tests."

Answered by AI

How many research subjects are required for this clinical trial?

"Yes, the information available onclinicaltrials.gov confirms that this study is looking for patients right now. The posting date was June 26th, 2019 and the most recent update was April 6th, 2020. They are hoping to enroll 136 people total from a single location."

Answered by AI

Can new patients still join this research project?

"This clinical trial, as detailed on clinicaltrials.gov, is looking for willing patients to participate. The study was first announced on June 26th 2019 with the most recent update being from April 6th 2022."

Answered by AI

Are there specific inclusion criteria for patients wanting to join this research?

"opioid addicts that are between 18 and 60 years old may be qualified to participate in this clinical trial--of which there are 136 planned slots."

Answered by AI

Does this research allow for patients who are octogenarians?

"The age restriction for this clinical trial is 18-60, with 22 other trials available to patients below the age of majority and 253 options for seniors."

Answered by AI

Could you please elaborate on the risks associated with taking Lofexidine?

"While there is some safety data from Phase 2 trials, none of it points to Lofexidine being an effective medication. Therefore, our team has rated its safety as a 2."

Answered by AI