The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

Eligible subjects will be Veterans with alcohol dependence during their first year of
recovery, 21-65 years old, with ISI total score of 15 or more, medically and psychiatrically
stable, and without dependence on other drugs (with the exception of nicotine and marijuana).

The proposed study will consist of a single-blind trial comparing CBT-I against a behavioral
placebo intervention (Quasi-Desensitization Therapy, QDT).

Baseline assessments conducted over a month will comprehensively evaluate for the addiction,
psychiatric, sleep and medical disorders, as well as for a family history of alcohol
dependence.

Once the subject is seen to be eligible for the study he will be randomized to either the
CBT-I or the QDT arm, and treated for the next weeks. The primary outcome measure for
insomnia will be the Insomnia Severity Index. The primary outcome measure for alcohol
dependence will be the percent days abstinent (on the Time Line Follow Back measure, TLFB),
and the daytime symptoms will be assessed using the Short Form-12 item scale (SF-12, for self
reported well-being), the Beck Depression Inventory (BDI, for depressive symptoms), and the
State Trait Anxiety Inventory (STAI, for anxiety symptoms).

After completion of the treatment phase, subjects will be followed up 3 months and 6 months
later, to assess for changes over time in their insomnia, alcohol use, and daytime
functioning.

Inclusion Criteria:

- Male and female Veterans between the ages of 21 and 70 years;

- DSM IV diagnosis of alcohol dependence over the past year (as determined by the
Structured Clinical Interview for DSM-IV Axis I Disorders [SCID-I]);

- Self-reported sleep latency or wake time after sleep onset >30 min on three or more
nights per week for 1 month and a score of 15 or more on the Insomnia Severity Index
(ISI);

- No current alcohol withdrawal symptoms at baseline: CIWA score < 8 (CIWA is the
Clinical Institute Withdrawal Assessment scale for alcohol withdrawal signs and
symptoms);

- 1 month and < 12 months of abstinence from alcohol prior to the baseline study
assessments as assessed by subjective report or breathalyzer;

- Ability to speak, understand and print in English;

- Capacity to give written informed consent.

Exclusion Criteria:

- DSM-IV criteria for dependence on any other substance including benzodiazepines (and
excluding nicotine dependence);

- Positive urine drug screen for opioids, cocaine, or amphetamine (positive screen for
Tetra Hydro Cannabinol is not considered an exclusion criteria);

- Patient is currently in alcohol withdrawal as assessed by the Clinical Institute
Withdrawal Assessment Scale (CIWA) total score of 8 or more;

- A lifetime DSM-IV diagnosis of Bipolar I or II disorder, Schizophrenia, or other
psychotic disorder, as determined on the SCID-I, and current (past month) DSM-IV
diagnosis of Major Depressive Disorder;

- Presence of unstable medical diagnosis e.g. congestive heart failure, leading to
interference with sleep, as reported on history, examination, and/or review of
clinical chart during baseline assessments;

- Current use of any medications that may influence the drinking behavior, e.g.
naltrexone or acamprosate;

- Evidence of severe cognitive impairment as assessed by the Blessed
Orientation-Memory-Concentration (BOMC) test weighted score;

- Untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with
Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep;

- Subject's inability to give informed consent.