Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

Duke University

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: ramelteon; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02156271

Pro00013501

Details and patient eligibility

About

The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

At screening visit:

• aged 18-65
• nonsmokers
• for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers

To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:

• ages 18-65 inclusive;

• PSQI-Component 2 (sleep latency) score of greater than 1;

• non-smoker (e.g., less than 20 cigarettes in the past 5 years);

• habitual bedtime between 8:30 pm and midnight

• For premenopausal women:

  • regular menstrual cycles determined by Framingham Study criteria;
  • not pregnant and no history of oral contraceptive (OC) usage in last 6-months.

• For postmenopausal women:

  • no recent (< 6 months) use of Hormone Replacement Therapy (HRT)
  • no surgical menopause

Exclusion criteria

• positive urine drug screen
• Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.
• Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.
• use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).
• Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

ramelteon

Active Comparator group

Description:

Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.

Treatment:

Drug: ramelteon

placebo

Placebo Comparator group

Description:

15 subjects will be randomized to receive the placebo

Treatment:

Drug: placebo