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Lofexidine + Buprenorphine for PTSD

Phase 2

Recruiting

Led By Christopher D. Verrico, PhD

Research Sponsored by Pharmacotherapies for Alcohol and Substance Abuse Consortium

Eligibility Criteria Checklist

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

Must have

Be on a stable dose of BUP maintenance therapy for at least 7 days at the same maintenance dose.

Be older than 18 years old

Must not have

Females of child-bearing potential must be using medically acceptable birth control (e.g. oral, implantable, injectable, or transdermal contraceptives; intrauterine device; double-barrier method) AND not be pregnant OR have plans for pregnancy or breastfeeding during the study.

Use of any of the following medications within 30 days prior to enrollment: Benzodiazepines, barbiturates, or other CNS depressants, Methadone or any other prescription analgesics, except BUP or BUP/naloxone, Opioid antagonists such as naltrexone, except naloxone in combination with BUP, Tricyclic antidepressants, Drugs that have been associated with QT prolongation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will test if adding the drug lofexidine to buprenorphine improves symptoms of both opioid use disorder and post-traumatic stress disorder in veterans.

Who is the study for?

This trial is for Veterans aged 18-65 with both PTSD and OUD, on stable buprenorphine therapy, who can consent in English. They must have normal lab tests (liver function up to 5X normal) and no severe health issues. Excluded are those with certain infections, other substance use disorders, recent methadone use, significant withdrawal symptoms or heart problems.

What is being tested?

The study aims to see if lofexidine helps improve PTSD and OUD symptoms when added to buprenorphine treatment in Veterans. Participants will either receive lofexidine or a placebo alongside their regular buprenorphine regimen to compare the effects on managing their conditions.

What are the potential side effects?

Potential side effects of lofexidine may include dry mouth, fatigue, insomnia, headache and hypotension (low blood pressure). Buprenorphine can cause constipation, nausea, inner sense of restlessness/need to move (akathisia), sweating and possible mild euphoria.

Eligibility Criteria

Inclusion Criteria

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

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I have been on a consistent dose of BUP for at least a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using reliable birth control and am not pregnant or planning to become pregnant or breastfeed during the study.

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I haven't taken certain medications like strong painkillers or specific antidepressants in the last 30 days.

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I have diabetes, pancreatitis, or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid Use

PTSD Symptoms (Checklist)

Secondary study objectives

Opioid Withdrawal

PTSD Symptoms

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

confusion

irritability

anxiety

gas

depression

sore throat

upper respiratory infection

decreased appetite

diarrhea

vomitting

stomache upset

abdominal pain

fever

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Lofexidine and Dronabinol

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lofexidine (LFX)Experimental Treatment1 Intervention

LFX starting dosage is two 0.2 mg LFX tablet taken orally 2 times daily (i.e., 0.8 mg/day). At study visit 2 (Day 3), the dosage is increased to 1.2mg/day (3 tablets, BID). At visit 3 (Day 5), the dose is increased to the target dose of 1.6mg/day (4 tablets, BID). Participants enter the flexible dosing period at visit 4, at which point the LFX dose can be maintained at 1.6 mg/day or decreased to 1.2 mg/day based on symptoms and the clinical judgement of the investigator. The flexible dosing period extends through to visit 6, however, doses will be adjusted during the study as needed.

Group II: Placebo (PLB)Placebo Group1 Intervention

A placebo drug will be employed as the comparison group to active study drug.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lofexidine

2010

Completed Phase 4

~1100

0 / 4Eligibility criteria met