Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
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ClinicalTrials.gov Identifier: NCT00781898 |
Recruitment Status :
Completed
First Posted : October 29, 2008
Results First Posted : October 23, 2017
Last Update Posted : October 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Addiction | Drug: Depot naltrexone Other: Treatment as Usual (TAU) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 308 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention of Relapse to Opioid Addiction Using Depot Naltrexone |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Depot Naltrexone |
Drug: Depot naltrexone
Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections. |
Placebo Comparator: Placebo |
Other: Treatment as Usual (TAU)
Treatment as Usual (TAU) community treatment provided to the participant |
- Relapse [ Time Frame: 6 months ]A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781898
United States, Pennsylvania | |
Treatment Research Center | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Charles P O'Brien, MD, PhD | University of Pennsylvania | |
Principal Investigator: | James W Cornish, MD | University of Pennsylvania | |
Principal Investigator: | Donna Coviello, PhD | University of Pennsylvania | |
Principal Investigator: | Peter Friedmann, MD, MPH | Rhode Island Hospital | |
Principal Investigator: | Timothy Kinlock, PhD | Mountain Manor Treatment Center, Baltimore MD | |
Principal Investigator: | Edward B. Nunes, MD | New York State Psychiatric Institute, New York, NY | |
Principal Investigator: | Josh Lee, MD | New York University/Bellevue |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00781898 |
Other Study ID Numbers: |
808422 R01DA024553 ( U.S. NIH Grant/Contract ) |
First Posted: | October 29, 2008 Key Record Dates |
Results First Posted: | October 23, 2017 |
Last Update Posted: | October 23, 2017 |
Last Verified: | September 2017 |
Depot naltrexone Parolees Opioid addiction prevention Medication Treatment Alternatives Prevention of Relapse to Opioid Addiction |
Opioid-Related Disorders Behavior, Addictive Compulsive Behavior Impulsive Behavior Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Naltrexone Alcohol Deterrents Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |