Overview

This trial is active, not recruiting.

Condition opiate addiction
Treatments depot naltrexone, treatment as usual (tau)
Phase phase 2/phase 3
Sponsor University of Pennsylvania
Collaborator National Institute on Drug Abuse (NIDA)
Start date June 2008
End date December 2014
Trial size 400 participants
Trial identifier NCT00781898, 808422, R01DA024553

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
depot naltrexone
Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
(Placebo Comparator)
treatment as usual (tau)
Treatment as Usual (TAU) community treatment provided to the participant

Primary Outcomes

Measure
Effect of Depot Naltrexone treatment on Opioid Use
time frame: Monthly during treatment phase (6 months)

Secondary Outcomes

Measure
Effect of Depot Naltrexone treatment on HIV risk behavior
time frame: baseline and monthly (for 6 months) during treatment phase
Effect of treatment on arrests and re-incarceration
time frame: Monthly, 6, 12 and 18 month post entry timepoint
Economic costs and benefit costs of naltrexone
time frame: Monthly and 6, 12 and 18 month post entry timepoint
Retention in treatment
time frame: Monthly and 6 month post entry timepoint
Ethical concerns about participants perceived voluntariness for study participation.
time frame: Baseline, month 2, 6, 12 and 18 month Follow-up

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Principal investigator Charles P O'Brien, MD, PhD
Description This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Pennsylvania.