Please select the eligibility criteria that correspond to the clinical trial below.
Title: Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Brief Summary: There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.


Options:
A: Inclusion Criteria:

* Enrolled patient at Community Psychiatric Clinic (CPC), a large mental health center in urban Seattle, Washington;
* Between 18 and 65 years of age;
* Diagnosis of of methamphetamine, amphetamine(illegal), or cocaine dependence or abuse;
* CPC medical record diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder
* Stimulant drug use one month before enrollment;
* Ability to understand written and spoken English;
* CPC clinical case manager must affirm the potential participant's ability to provide informed consent and clinical appropriateness (i.e., safety/severity of mental/substance/ physical health) to participate in the study.

Exclusion Criteria:

* Any medical/psychiatric condition, or severity of that condition, that, in the opinion of Dr. Ries, the PI, would compromise safe study participation
* Chart defined organic brain disorder or dementia;
* Current participation in a methadone maintenance program;
* Any other circumstances that in the PI's opinion precludes safe study participation.
B: Inclusion Criteria for Step 1:

* alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
* age 18-65,
* adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
* willingness to give written consent,
* abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
* resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).

Exclusion Criteria for Step 1:

* sensitivity to study medications or therapy with these drugs within 6 months,
* active major psychiatric disorder associated with significant suicide risk,
* pregnancy or lactation,
* advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
* other serious medical illness that would interfere with adherence to the study protocol.

Entry criteria to step 2:

* Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
* case formulation and diagnosis for anxiety or depression (see below).

Exclusion criteria 2:

* Non-compliance on acamprosate and/or naltrexone,
* alcohol consumption at baseline levels,
* resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment
C: Inclusion Criteria:

* HIV seropositive
* Currently enrolled in methadone maintenance treatment for at least one month
* Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))
* Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
* Between the ages of 18 and 65.

Exclusion Criteria:

* Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S \>6)
* Unable or unwilling to provide informed consent.
* Currently in cognitive behavioral therapy for depression.
D: Inclusion Criteria:

* smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
* willing to use the transdermal nicotine patch
* report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

Exclusion Criteria:

* are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
* taking prescribed psychotropic medication or receiving other forms of psychotherapy
* concomitantly using other pharmacotherapies for smoking cessation
* have any contraindications for use of the transdermal nicotine patch.

Answer: B