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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
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Inclusion criteria
Exclusion criteria
Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
Recent use of any prescribed therapy that is taken specifically for hot flashes
Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
Recent use of any prescribed medications with known hot flash efficacy
Known hypersensitivity or contraindications (reasons not to take) to gabapentin
Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
Recent drug or alcohol abuse
Lifetime diagnosis of psychosis or bipolar disorder
Suicide attempt in the past 3 years or any current suicidal ideation
Current major depression (assessed during screening)
Pregnancy, intending pregnancy, or breast feeding
History of:
Any unstable medical condition
Working a night/rotating shift
Abnormal screening blood tests
Current participation in another drug trial or intervention study
Inability or unwillingness to complete the study procedures
Primary purpose
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Interventional model
Masking
32 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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