Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Brief Summary: Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.

This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.


Options:
A: Inclusion Criteria:

* Adults incarcerated in NYC jails with known release date
* DSM-IV criteria for current opioid dependence
* No current agonist (methadone, buprenorphine) treatment
* Currently opioid free by history ('detoxed') and with a negative urine for all opioids
* General good health as determined by complete medical interview and physical examination
* Age 18-60 years.

Exclusion Criteria:

* History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
* Pregnancy, lactation, or planning conception
* Active medical illness that might make participation hazardous
* Untreated psychiatric disorder
* History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
* Current chronic pain condition treated with opioids.
B: Inclusion Criteria:

* Be between the ages of 18 and 60;
* Have dx of opioid dependence according to DSM-IV criteria
* be in good general health as determined by complete physical and laboratory tests;
* Under some form of criminal justice supervision for at least 12 months;
* Have a negative result for urinary opioids and no sign of opiate withdrawal after IV (or IM) injection of 0.8 mg of naloxone; and
* Express a goal of opiate free treatment rather than agonist maintenance

Exclusion Criteria:

* Current drug or alcohol dependence that requires medical supervision;
* untreated psychiatric disorders that might make participation hazardous (e.g. untreated psychosis, bipolar disorder with mania, significant suicide risk). Adequately treated psychiatric disorders and appropriate psychotropic medications would be allowed.

  3. Active medical illness that might make participation hazardous (e.g., untreated hypertension, hepatitis with AST or ALT \>3 times upper limit of normal, unstable diabetes or heart disease). Adequately treated medical conditions are acceptable; 4. female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant); 5. Liver failure or liver function test levels greater than three times normal; 6. History of allergic reaction to naltrexone; 7. History of a drug overdose in the past 3 years; and 8. Current diagnosis of chronic pain disorder for which opioids are prescribed for pain relief.
C: Inclusion Criteria:

1. Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
2. Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
3. Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).
4. Ability to be rated on psychiatric rating scales.
5. Willingness to take long-acting injectable medication.
6. Currently receiving treatment at a Community Mental Health Clinic (CMHC) or another mental health treatment provider who is able to provide continuity of care during and after study participation.
7. Able to provide written, informed consent to study participation.
8. Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.

Exclusion Criteria:

1. Known resistance or intolerance to haloperidol or haloperidol decanoate.
2. Medical contraindication to haloperidol or haloperidol decanoate.
3. Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
4. Prior or current treatment with clozapine.
5. Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.
6. Current substance dependence.
7. High risk of harm to self or others.
8. Female who is currently pregnant or breastfeeding.
9. Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).
D: Inclusion Criteria:

1. Meets DSM-IV criteria for opioid dependence
2. Age \> 18 years
3. Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
4. Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
5. No participation in pharmacotherapy trial in the previous 30 days
6. Not pregnant

Exclusion Criteria:

1. Unable to provide informed consent
2. Verbally or physically threatening to research staff
3. Unable to communicate in either English or Spanish
4. Pending trials for a felony
5. Liver failure (Childs-Pugh Class B or C Cirrhosis)
6. Grade IV Hepatitis (liver function tests \> 10X normal)
7. Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
8. Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
9. Active opioid withdrawal (within 3-5 days since last opioid ingestion)
10. Pregnancy or unwilling to take contraceptives measures
11. Breast-feeding

Answer: C