Menopause | Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Menopause research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:GabapentinThe 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Open-label gabapentinDose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Start Date: January 2014
Completed Date: August 2015
Primary Outcome: Tolerability of Gabapentin
Study sponsors, principal investigator, and references
Principal Investigator: Lee S Cohen, MD
Lead Sponsor: Massachusetts General Hospital
Collaborator: Brigham and Women's Hospital
Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55.