Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Brief Summary: The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.


Options:
A: Inclusion Criteria:

* qualify for a DSM-IV lifetime diagnosis of cocaine dependence and cocaine use in 6 months prior to treatment;
* initial engagement in IOP, as indicated by attendance at 4 or more sessions in the first two weeks of treatment;
* 18 to 75 years of age;
* willingness to be randomized and participate in research.
* metropolitan area residents;
* able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up.

Exclusion Criteria:

* current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
* acute medical problem requiring immediate inpatient treatment;
* current participation in methadone or other forms of DA treatment, other than IOP
B: Inclusion Criteria:

In order to participate in the study, subjects must

* Be at least 18 years of age and no older than 55 years of age.
* Weigh more than 100 pounds.
* Have a DSM-IV diagnosis of cocaine dependence.
* Be seeking treatment for cocaine dependence.
* Have a urine sample positive for qualitative cocaine toxicology at initial screening.
* Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
* Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the Principal Investigator.
* Have normal, or, if necessary, corrected visual acuity, visual fields, and normal fundoscopy findings

Exclusion Criteria:

* In order to participate in the study, subjects must not:

  * Meet DSM-IV criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  * Have neurological or psychiatric disorders such as: psychosis, bipolar illness, major depression, organic brain disease, dementia, any disorder which would require ongoing treatment or which would make study agent compliance difficult, history of suicide attempts assessed and/or current suicidal ideation/plan.
  * Have serious medical illnesses or other potentially life threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct.
  * Have a history of traumatic head injury.
  * Be mandated by a court to obtain treatment for cocaine dependence.
  * Have been treated for cocaine addiction, or abstained from cocaine use for a significant period, within the 6 months preceding screening.
  * Be unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
  * Have AIDS (although AIDS is an exclusion criterion, a positive antibody titer to HIV is not).
  * Have active syphilis that has not been treated or refuse treatment for syphilis
  * Have a history of neuroleptic malignant syndrome.
  * Have known or suspected hypersensitivity to vigabatrin or any other GABAergic drug.
  * Have received a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
  * Have participated in any experimental study within 4 weeks, or participated in any clinical trial utilizing vigabatrin.
  * Be pregnant or lactating.
  * Have any clinically significant abnormal laboratory value.
  * Have had electroconvulsive therapy with the 3 months preceding screening.
  * Have had any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months preceding screening.
  * Have a history of i.v. cocaine (or other psychoactive drug) use within 2 months preceding screening.
  * Have a current or past history of seizure disorder, including alcohol- or stimulant related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
  * Have a visual field defect, or factor predisposing to visual field defects, including glaucoma, severe myopia, retinal disorder, cataracts, diabetes or uncontrolled hypertension.
  * Have my illness, condition, and use of medications, in the opinion of the Principal Investigator and the admitting physician, which would preclude safe or successful completion of the study.
  * Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:

    * A) Five half-lives of other medication or active metabolite(s), whichever is longer;
    * B) Two weeks.
  * Be lactose intolerant.
C: Specific site inclusion criteria include: (a) ability to provide youth service records, (b) service to youth under community supervision, (c) access to treatment provider(s) if treatment is not provided directly by the JJ agency, (d) participation in requisite intervention training/activities,(e) minimum average case flow of 10 youth per month, (f) minimum of 10 staff per site, and (g) a senior JJ staff member who agrees to serve as site leader/liaison during the study. Study sites are geographically dispersed and were identified by state JJ agencies (and not selected for particular substance use or related BH service needs).

Youth inclusion criteria include: all youth entering the juvenile justice system during the period within the exception of those who are already in treatment at the time that they are referred to the juvenile justice agency.

Staff inclusion criteria include: all staff actively working with the youth under community supervision in the site with exclusion only of higher level administrative or regional staff over multiple units..
D: 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.

Answer: D