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Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

NCT05685407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-22

No results posted yet for this study

Summary

Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.

Conditions

  • Female Sexual Arousal Disorder

Interventions

DRUG

Caffeine

300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.

OTHER

Placebo

A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Cindy M Meston, PhD · The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-04-15
Completion
2023-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685407 on ClinicalTrials.gov