Effect of Ramelteon on Smoking Abstinence

Inclusion Criteria

• Smokers who are between 18 and 65 years of age who self-report smoking at least 10 cigarettes per day for at least the last 6 months.
• Interest in quitting smoking in the next 2 to 4 months.
• Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Women of childbearing potential must consent to use a medically accepted method of birth control while participating in the study (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).

Exclusion Criteria

Smoking Behavior:

• Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months.
• Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes.
• Provide a carbon monoxide (CO) breath sample reading less than 10 parts per million (ppm) at Intake.

Alcohol/Drugs:

• Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months. Subjects will be told to limit or avoid the use of alcohol while in the study to avoid any adverse reactions to the study medication.
• Self-reports substance use disorders (abuse or dependence involving alcohol, opiates, cocaine or other stimulants, or benzodiazepines; not nicotine) in the last 6 months.
• Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 during any session.
• A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, marijuana, ecstasy (MDMA), oxycodone, tricyclic antidepressants, and opiates (low level cut-off 300 ng/mL) during any session.

Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Intake):

• Current psychiatric disorders (depression, bipolar, schizophrenia, hypomanic/manic episode) as determined by self-report and/or MINI psychological interview.
• Past history of psychiatric disorders (including suicide attempt) other than depression as determined by self-report and/or MINI psychological interview.
• Suicide risk score on MINI greater than 1.

Medical:

• Females who are currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating. All female subjects shall undergo a urine pregnancy test at the Intake and must agree in writing to use an approved method of contraception. Following enrollment, pregnancy tests will be conducted at the beginning of each baseline week.
• For those with a history of jaundice/liver disease: liver function tests more than 20% outside of the normal range; Gamma-glutamyl Transpepsidase (GGT) values more than 20% outside of the normal range. If Albumin/Globulin ratios are 20% outside of normal range the abnormal value will be evaluated for clinical significance by the Study Physician and eligibility will determined on a case-by-case basis.
• Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months.
• Endocrine or metabolic disorders (e.g., Type-I diabetes).
• Blood disorders (e.g., anemia or hemophilia).
• Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*.
• Clinically significant dyssomnia (except insomnia; e.g. sleep apnea syndrome, narcolepsy).
• Participants presenting with SBP greater than 159 mmHg and/or DBP greater than 99 mmHg at the Intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be instructed to sit comfor