CompletedPhase 2

Impact of Lofexidine on Stress, Craving and Opioid Use

United States112 participantsStarted 2019-06-26

Plain-language summary

Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
. Meet DSM-5 criteria for opioid use disorder (within the past three months). While individuals may also meet criteria for mild use disorders of other substances, they must identify opioids as their primary substance of abuse and must not meet criteria for any other moderate or severe substance use disorder (except tobacco, caffeine, or marijuana) within the last 60 days.
. On a stable dose of daily buprenorphine or methadone for at least 2 weeks.
. Age 18-65.
. Women of childbearing potential must agree to use an effective means of birth control.
. Consent to remain abstinent from opioids during the 1-week baseline assessment period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Drug Cue+ Stressor Induced Craving

Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-Baseline

Drug Cue+ Stressor Induced Stress Response

Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-Baseline

Trial details

NCT IDNCT03718065

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

Results submitted2025-01-02

View on ClinicalTrials.gov More Opioid-use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
. Meet DSM-5 criteria for opioid use disorder (within the past three months). While individuals may also meet criteria for mild use disorders of other substances, they must identify opioids as their primary substance of abuse and must not meet criteria for any other moderate or severe substance use disorder (except tobacco, caffeine, or marijuana) within the last 60 days.
. On a stable dose of daily buprenorphine or methadone for at least 2 weeks.
. Age 18-65.
. Women of childbearing potential must agree to use an effective means of birth control.
. Consent to remain abstinent from opioids during the 1-week baseline assessment period.

What they're measuring

Drug Cue+ Stressor Induced Craving

Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-Baseline

Drug Cue+ Stressor Induced Stress Response

Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-Baseline

Impact of Lofexidine on Stress, Craving and Opioid Use

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Impact of Lofexidine on Stress, Craving and Opioid Use

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria