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

NCT ID: NCT02156271

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

Brief Summary

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ramelteon

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.

Group Type: ACTIVE_COMPARATOR

ramelteon

Intervention Type: DRUG

placebo

15 subjects will be randomized to receive the placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

ramelteon

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Rozerem

Eligibility Criteria

Inclusion Criteria

At screening visit:

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Krystal, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00013501

Identifier Type: -

Identifier Source: org_study_id