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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; National Institute on Aging (NIA)
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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