Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01014533
Eligibility Criteria:
Inclusion Criteria:
* Meet DSM-IV criteria for alcohol dependence (as confirmed by the SCID)
* Between 3 and 12 weeks since last drink (as measured by the TLFB)
* At least 2 weeks since last detoxification medication, if relevant
* An alcohol withdrawal rating score \< 8 (as measured by the CIWA-Ar) to rule out acute alcohol withdrawal effects on sleep.
* Expresses a desire to stop drinking or a willingness to abstain from alcohol and/or other drugs of abuse (except nicotine) during the course of the study
Exclusion Criteria:
* Subjects who meet DSM-IV criteria for dependence on any psychoactive substance other than alcohol (except nicotine) in the past 3 months (per SCID interview).
* Subjects with a current (past 1 month) DSM-IV diagnosis of panic disorder, generalized anxiety disorder, post-traumatic stress disorder, major depression, anorexia nervosa, or bulimia nervosa (per SCID interview) and/or that require ongoing psychotropic medication.
* Subjects who have a lifetime diagnosis meeting DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, delusional (paranoid) disorders, or obsessive-compulsive disorder.
* Urine drug screen positive for amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, or opioids. (If positive, subjects have one opportunity to test negative after a week of abstinence).
* Medical disorders or pain syndromes that may affect sleep; history of head trauma with loss of consciousness; history of seizures (except alcohol-related seizures).
* Subjects with elevated renal tests (blood urea nitrogen or creatinine), because gabapentin is renally eliminated, or elevated liver transaminases (\>3X normal), or abnormal thyroid tests as thyroid problems can affect sleep.
* Sleep disorders other than insomnia such as sleep apnea/hypopnea index \>10 per hour or periodic limb movement disorder; PLM\>15 movements per hour with arousals.
* Taking medications known to affect sleep (e.g., antidepressants, anticonvulsants, centrally acting antihistamines, neuroleptics, sedative-hypnotics, stimulants, centrally acting antihypertensives \[alpha-methyldopa, reserpine, clonidine\], oral corticosteroids, and theophylline within the past 2 weeks or 5 weeks for fluoxetine).
* Subjects taking medications used to treat addiction (e.g., disulfiram, naltrexone or acamprosate) are excluded because of unknown effects on sleep.
* Subjects who do evening or midnight shift work. (Subjects who have traveled across multiple time zones in the previous two weeks will be included only at the discretion of the P.I.)
* Pregnancy, breast feeding, or inadequate contraception in women of child-bearing potential.
* Subjects who are unable or unlikely to follow the study protocol in the investigator 's opinion, because of cognitive deficits (Mini-Mental State Exam score \< 27), a personality disorder, a serious suicide risk, dangerousness to others, illiteracy, or unstable or distant living situation.
* Subjects with a known allergy, hypersensitivity or contraindication to study medication.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01014533
Study Brief:
Protocol Section:
NCT01014533