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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been on a consistent dose of BUP for at least a week.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Use
PTSD Symptoms (Checklist)
Secondary outcome measures
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%
gas
5%
confusion
5%
anxiety
5%
irritability
5%
depression
3%
upper respiratory infection
3%
sore throat
3%
decreased appetite
3%
diarrhea
3%
vomitting
3%
stomache upset
2%
fever
2%
abdominal pain
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
6 Previous Clinical Trials
109 Total Patients Enrolled
RTI InternationalOTHER
188 Previous Clinical Trials
875,844 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

Frequently Asked Questions

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

Is there a minimum age requirement for participation in this medical experiment?

"The eligibility criteria for this trial necessitates that interested participants must be between the age of majority and 65 years old."

Answered by AI

What is the current capacity of participants for this clinical research?

"Affirmative. According to clinicaltrials.gov, the trial publicized on March 9th 2021 is actively in search of participants. 120 individuals are required for this experiment which will occur at 1 site and was last modified April 11th 2022"

Answered by AI

Do any other research projects make use of Lofexidine?

"Currently, there are 5 clinical trials underway for Lofexidine, with one of them having entered Phase 3. Baltimore is the epicentre for these studies; nonetheless, 7 medical centres across the nation are researching this medication."

Answered by AI

Is this experiment actively seeking participants?

"Affirmative. Per the information on clinicaltrials.gov, this research is currently recruiting participants with a start date of March 9th 2021 and an update as recent as April 11th 2022. A total of 120 patients are needed for enrollment at 1 medical site."

Answered by AI

Who meets the criteria for participation in this research project?

"This clinical trial is recruiting 120 individuals with a diagnosis of PTSD, aged 18 to 65. To qualify for the study, participants must satisfy these conditions: male or female gender, capable of comprehending English language instructions, legally able to provide written informed consent (exclusion criteria includes minors and prisoners), documented history of PTSD in CPRS reports or CAPS-5 ratings within 3 months prior to enrollment; normal hematology/chemistry values except liver function tests which can be up to 5x upper limit; 7+ days on stable BUP maintenance therapy dosage regimen at time of screening; positive urine toxicology screen for BUP; medical"

Answered by AI

Has the Food and Drug Administration authorized Lofexidine for public usage?

"Since the study is in its second phase, our team has rated Lofexidine's safety as a 2 due to existing data on safety but no proof of efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Michael E. DeBakey Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans
2021. "Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04360681.
All > Ptsd Houston
~19 spots leftby Nov 2024
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