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

Sponsor
University of Texas at Austin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05685407
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Caffeine

During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine.

Drug: Caffeine
300mg caffeine will be administered to participants with female sexual arousal disorder.
Placebo Comparator: Placebo

During one of two counterbalanced experimental sessions, participants will ingest placebo.

Drug: Caffeine
300mg caffeine will be administered to participants with female sexual arousal disorder.

Outcome Measures

Primary Outcome Measures

  1. Vaginal pulse amplitude [15 minutes post-ingestion of caffeine and placebo]

    Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow

Secondary Outcome Measures

  1. Subjective sexual arousal [30 minutes post-ingestion of caffeine and placebo]

    Subjective sexual arousal is positive cognitive engagement in response to a sexual stimulus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Between the of ages 18-55

  • Fluent in English

  • Experience antidepressant-induced arousal difficulties

  • Experience regular menstrual periods (i.e., not perimenopausal or menopausal)

Exclusion Criteria:

  • A history or current diagnosis of panic attacks or panic disorder

  • A history or current diagnosis of sexually transmitted disease(s)

  • A history of major pelvic surgery that caused nerve damage

  • Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response

  • Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage)

  • A history of childhood sexual abuse (CSA) that occurred prior to age 16

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas at Austin, Sexual Psychophysiology Laboratory Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

  • Principal Investigator: Cindy M Meston, PhD, The University of Texas at Austin

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT05685407
Other Study ID Numbers:
  • 00002778
First Posted:
Jan 17, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by University of Texas at Austin
female sexual dysfunction
female sexual arousal disorder
caffeine
Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Caffeine

Study Results

No Results Posted as of Jan 17, 2023