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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
Awards & highlights

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 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
8%
sweating
7%
orthostasis
5%
confusion
5%
irritability
5%
anxiety
5%
gas
5%
depression
3%
sore throat
3%
upper respiratory infection
3%
decreased appetite
3%
diarrhea
3%
vomitting
3%
stomache upset
2%
abdominal pain
2%
fever
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Pharmacotherapies for Alcohol and Substance Abuse ConsortiumLead Sponsor
3 Previous Clinical Trials
79 Total Patients Enrolled
Pharmacotherapies for Alcohol and Substance Use Disorders AllianceLead Sponsor
7 Previous Clinical Trials
149 Total Patients Enrolled
RTI InternationalOTHER
195 Previous Clinical Trials
817,063 Total Patients Enrolled

Media Library

Lofexidine Clinical Trial Eligibility Overview. Trial Name: NCT04360681 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Lofexidine (LFX), Placebo (PLB)
Post-Traumatic Stress Disorder Clinical Trial 2023: Lofexidine Highlights & Side Effects. Trial Name: NCT04360681 — Phase 2
Lofexidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04360681 — Phase 2
~5 spots leftby Nov 2024
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