Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women

Mass General Brigham

Status: Completed

Conditions: Menopause; Vasomotor Disturbance; Hot Flashes

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02040532

5U01AG032700-05 (U.S. NIH Grant/Contract)

2013P002196

Details and patient eligibility

About

The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.

Full description

Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled into this open-label pilot study. The study was a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks. The intervention study followed a 3-week screening period to establish a stable baseline for insomnia symptoms and VMS and to determine the safety of administering gabapentin in study participants. Tolerability and treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each study visit. The dose titration schedule was followed in all participants unless there are dose-limiting toxicities.

Enrollment: 32 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females aged 40-65 years
2. Postmenopausal or perimenopausal
3. Having bothersome hot flashes
4. Having some bothersome hot flashes during the night
5. Insomnia or problems sleeping
6. In general, good health
7. Signed informed consent

Exclusion criteria

1. Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)

2. Recent use of any prescribed therapy that is taken specifically for hot flashes

3. Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes

4. Recent use of any prescribed medications with known hot flash efficacy

5. Known hypersensitivity or contraindications (reasons not to take) to gabapentin

6. Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period

7. Recent drug or alcohol abuse

8. Lifetime diagnosis of psychosis or bipolar disorder

9. Suicide attempt in the past 3 years or any current suicidal ideation

10. Current major depression (assessed during screening)

11. Pregnancy, intending pregnancy, or breast feeding

12. History of:

    1. Renal insufficiency or a kidney disorder
    2. Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy

13. Any unstable medical condition

14. Working a night/rotating shift

15. Abnormal screening blood tests

16. Current participation in another drug trial or intervention study

17. Inability or unwillingness to complete the study procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Open-label gabapentin

Experimental group

Description:

Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.

Treatment:

Drug: Gabapentin