Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/25/2017 |
| Start Date: | June 2008 |
| End Date: | August 2015 |
Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
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.
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.
This site serves as the coordinating center for five sites conducting the trial under the
same IND and same protocol.
same IND and same protocol.
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.
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