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

NCT ID: NCT02040532

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-08-31

Brief 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.

Detailed 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.

Conditions

Menopause; Hot Flashes; Vasomotor Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label gabapentin

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

The study is 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.

Interventions

Gabapentin

The study is 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.

Intervention Type: DRUG

Other Intervention Names

Neurontin

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lee S. Cohen, MD

Director, Center for Women's Mental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee S Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Other Identifiers

5U01AG032700-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013P002196

Identifier Type: -

Identifier Source: org_study_id