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

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Female Sexual Arousal Disorder

Treatments: Drug: Caffeine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05685407

00002778

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Caffeine

Experimental group

Description:

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

Treatment:

Drug: Caffeine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo