Trial · NCT03718065

Impact of Lofexidine on Stress, Craving and Opioid Use

NCT03718065, Phase 2, Completed, Medical University of South Carolina; results first posted 2025-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Impact of Lofexidine on Stress, Craving and Opioid Use. Trials, record NCT03718065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03718065

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Impact of Lofexidine on Stress, Craving and Opioid Use
NCT number: NCT03718065
Status: Completed
Phases: Phase 2
Enrollment: 112 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Opioid-use Disorder, Opiate Dependence
Interventions: Lofexidine, Placebo
First posted: 2018-10-24
Last updated: 2025-02-07
Results first posted: 2025-02-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Drug Cue+ Stressor Induced Craving	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	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.
Primary	Drug Cue+ Stressor Induced Stress Response	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	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Drug Cue+ Stressor Induced Craving	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	Participants with available data on the Trier Social Stress Task (TSST) or Scripted Imagery Cue (Cue). TSST and Cue Tasks were counterbalanced.	units on a scale	MEAN
PRIMARY	Drug Cue+ Stressor Induced Stress Response	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	Participants with available data on the Trier Social Stress Task (TSST) or Scripted Imagery Cue (Cue). TSST and Cue Tasks were counterbalanced.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group80

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Drug Cue+ Stressor Induced Craving	Lofexidine Men	Pre-Cue	1.52	Standard Deviation 1.56	units on a scale
Drug Cue+ Stressor Induced Craving	Lofexidine Women	Pre-Cue	1	Standard Deviation 0	units on a scale
Drug Cue+ Stressor Induced Craving	Placebo Men	Pre-Cue	1.72	Standard Deviation 1.69	units on a scale
Drug Cue+ Stressor Induced Craving	Placebo Women	Pre-Cue	1.96	Standard Deviation 1.61	units on a scale
Drug Cue+ Stressor Induced Craving	Lofexidine Men	Cue + 0 Minutes	2.33	Standard Deviation 2.06	units on a scale
Drug Cue+ Stressor Induced Craving	Lofexidine Women	Cue + 0 Minutes	3.58	Standard Deviation 2.97	units on a scale
Drug Cue+ Stressor Induced Craving	Placebo Men	Cue + 0 Minutes	2.05	Standard Deviation 2.10	units on a scale
Drug Cue+ Stressor Induced Craving	Placebo Women	Cue + 0 Minutes	3.56	Standard Deviation 2.54	units on a scale
Drug Cue+ Stressor Induced Craving	Lofexidine Men	Cue + 5 Minutes	2	Standard Deviation 1.75	units on a scale
Drug Cue+ Stressor Induced Craving	Lofexidine Women	Cue + 5 Minutes	2.74	Standard Deviation 3.02	units on a scale

1 to 10 of 80Source ClinicalTrials.gov

See all 80 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lofexidine Men	35
Overall Study	STARTED	Lofexidine Women	24
Overall Study	STARTED	Placebo Men	24
Overall Study	STARTED	Placebo Women	29
Overall Study	COMPLETED	Lofexidine Men	30
Overall Study	COMPLETED	Lofexidine Women	18
Overall Study	COMPLETED	Placebo Men	23
Overall Study	COMPLETED	Placebo Women	25
Overall Study	NOT COMPLETED	Lofexidine Men	5
Overall Study	NOT COMPLETED	Lofexidine Women	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dry Mouth	Endocrine disorders	Lofexidine Men	18	35	21
other	Dry Mouth	Endocrine disorders	Lofexidine Women	12	24	13
other	Dry Mouth	Endocrine disorders	Placebo Men	4	24	4
other	Dry Mouth	Endocrine disorders	Placebo Women	5	29	5
other	Tiredness/Drowsiness	Nervous system disorders	Lofexidine Men	15	35	17
other	Tiredness/Drowsiness	Nervous system disorders	Lofexidine Women	8	24	10
other	Tiredness/Drowsiness	Nervous system disorders	Placebo Men	3	24	3
other	Tiredness/Drowsiness	Nervous system disorders	Placebo Women	4	29	6
other	Dizziness	Nervous system disorders	Lofexidine Men	7	35	7
other	Dizziness	Nervous system disorders	Lofexidine Women	2	24	2

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lofexidine Men	0	35
Total, all-cause mortality	Lofexidine Women	0	24
Total, all-cause mortality	Placebo Men	0	24
Total, all-cause mortality	Placebo Women	0	29
Total, other adverse events	Lofexidine Men	28	35
Total, other adverse events	Lofexidine Women	17	24
Total, other adverse events	Placebo Men	10	24
Total, other adverse events	Placebo Women	13	29
Total, serious adverse events	Lofexidine Men	0	35
Total, serious adverse events	Lofexidine Women	0	24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34737091	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U54DA016511	MUSC Specialized Center of Research Excellence on Sex Differences Renewal 2022	MCRAE-CLARK, AIMEE L; TOMKO, RACHEL LYNN	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON DRUG ABUSE	2018 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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