Impact of Lofexidine on Stress, Craving and Opioid Use

Browse trials for

• Opioid-Related Disorders 1,411

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 112 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Study arms

• Experimental
  Lofexidine Men

  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.

  Drug: Lofexidine

• Experimental
  Lofexidine Women

  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.

  Drug: Lofexidine

• Placebo comparator
  Placebo Men

  Men will receive matching placebo for five weeks.

  Drug: Placebo

• Placebo comparator
  Placebo Women

  Women will receive matching placebo for five weeks.

  Drug: Placebo

Interventions

• DrugLofexidine

  Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.

  Also known as: Lucemyra

• DrugPlacebo

  Placebo comparator.

Primary outcomes

1. Drug Cue+ Stressor Induced Craving

   Participants will rate craving on a 0 to 7 Likert scale with 0 indicate "Strongly disagree" that they crave and 7 indicating "strongly agree" that they crave so that higher scores indicate more craving.

   Time frame: 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

2. Drug Cue+ Stressor Induced Stress Response

   Participants will rate stress on a 0 to 4 Likert scale with 0 indicate "not at all" and 4 indicating "extremely" so that higher scores indicate a more robust stress response.

   Time frame: 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

Baseline characteristics

Publications

• Guille C, King C, Ramakrishnan V, Baker N, Cortese B, Nunn L, Rogers T, McRae-Clark A, Brady K. The impact of lofexidine on stress-related opioid craving and relapse: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Dec;111:106616. doi: 10.1016/j.cct.2021.106616. Epub 2021 Nov 2. PubMed 34737091 ↗

Study documents

• Protocol, analysis plan and consent form · Jul 25, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No