Clinical trial NCT00434876: The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Official title: The Effects of Quetiapine on Sleep During Alcohol Abstinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcoholism
Sleep Initiation and Maintenance Disorders
Keywords: Alcoholism
Insomnia
Quetiapine
Seroquel
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2007-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.

Detailed description: Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. Novel antipsychotic medications such as quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia.

The primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence. The sleep efficiency from an in-lab polysomnogram will be the primary outcome measure. Secondary measures of sleep will include the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and actigraphy. Other additional aims will explore for alcohol use and cravings, change in psychiatric symptoms using the The Time Line Follow Back measure, Penn Alcohol Craving Scale (PACS), the Patient Health Questionnaire-9 item scale (PHQ-9), and the Beck's Anxiety Inventory (BAI) respectively.

Twenty four subjects within the first year of sobriety will be enrolled. Participants will be undergo an extensive baseline screening procedure. After 2 consecutive in-laboratory polysomnograms they will be treated with either Quetiapine XR or matching placebo pills targetting a dose of 400 mg a night. The treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram. All subjects will also receive Medical Management therapy, a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance.

Eligibility criteria: Inclusion Criteria: subjects between the ages of 18-65 years, with a DSM-IV diagnosis of current alcohol dependence (past year), can speak, understand, and print in English, and is capable of giving written informed consent

Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts \[posterior capsular/ nuclear (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.

Primary outcomes:
measure: Sleep Efficiency (From an In-laboratory Polysomnogram)
timeFrame: Baseline, and week 8 of treatment.
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, weeks 1, 3, 5, and 7 of treatment.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, weeks 4, and 9.
measure: Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
timeFrame: Baseline, and week 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia, OPC
state: Pennsylvania
Study officials:
affiliation: Philadelphia, OPC
name: Subhajit Chakravorty, MD
role: PRINCIPAL_INVESTIGATOR
References: