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

NCT05685407 | Completed Phase 1 FDA Drug

• 1 other identifier: 00002778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Arousal Disorder

Keywords

female sexual dysfunction; female sexual arousal disorder; caffeine

Outcome Measures

Primary Outcomes (1)

• Vaginal pulse amplitude via vaginal photoplethysmography

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

  15 minutes post-ingestion of caffeine and placebo

Secondary Outcomes (1)

• Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale

  30 minutes post-ingestion of caffeine and placebo

Study Arms (2)

Caffeine

EXPERIMENTAL

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

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Caffeine DRUG

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

Caffeine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the of ages 18-55
• Fluent in English
• Experience antidepressant-induced arousal difficulties
• Experience regular menstrual periods (i.e., not perimenopausal or menopausal)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin, Sexual Psychophysiology Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cindy M Meston, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: January 1, 2023
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)