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

NCT ID: NCT05685407

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caffeine

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

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Caffeine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy M Meston, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin, Sexual Psychophysiology Laboratory

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

00002778

Identifier Type: -

Identifier Source: org_study_id