# Impact of lofexidine on anxiety, craving and opioid use in opioid-dependent men and women

> **NIH NIH U54** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2020 · $481,189

## Abstract

ABSTRACT
Opioid use disorders (OUDs) are increasing at alarming rates in women. Stress and dysregulation in biologic
stress response systems appear to play an important role in drug use, and the connection between stress and
drug use may be particularly important for women. Alterations in the hypothalamic-pituitary-adrenal axis and
noradrenergic system are important in pathophysiology of OUDs. There is evidence that alpha-2 adrenergic
agonists, agents that decrease noradrenergic activity, may help to prevent relapse and decrease stress reactivity
in individuals with OUD and prevent relapse to drug use. Of interest, alpha-2 adrenergic agents have
demonstrated greater effect in decreasing stress-reactivity and craving in cocaine- and nicotine-dependent
women as compared to men, but gender differences in the impact of alpha-2 adrenergic agents in individuals
with OUD have not been systematically explored. In the proposed study, we will explore the impact of a new
alpha-2 adrenergic agent, lofexidine, on stress and drug cues in a laboratory paradigm and on stress cues
delivered in participants' natural environments over the course of a 4-week clinical trial in 208 opioid-dependent
men and women (104 women, 104 men). We will use innovative mobile technology to measure response to
stress cues repeatedly before, during, and after treatment to allow for assessment of craving, emotional state
and stress-cue reactivity in the natural environment of women and men with OUD. We will also measure urine
drug screens three times per week and assess medication compliance using an innovative video capture
procedure. The proposed study has significant synergies with Projects 1 and 3, utilizing similar assessment and
pharmacologic interventions, respectively. This project will provide important information about a novel treatment
strategy which may expand personalized medicine strategies for individuals with OUD.

## Key facts

- **NIH application ID:** 9991817
- **Project number:** 5U54DA016511-18
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** KATHLEEN T. BRADY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $481,189
- **Award type:** 5
- **Project period:** 2002-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9991817

## Citation

> US National Institutes of Health, RePORTER application 9991817, Impact of lofexidine on anxiety, craving and opioid use in opioid-dependent men and women (5U54DA016511-18). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9991817. Licensed CC0.

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