Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

Opiate Addiction Clinical Trial

Official title:

Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781898
• Other study ID #: 808422
• Secondary ID: R01DA024553
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 24, 2008
• Last updated: September 21, 2017
• Start date: June 2008
• Est. completion date: August 2015

Study information

• Verified date: September 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Opiate Addiction
• Opioid-Related Disorders

Intervention

Drug:
• Depot naltrexone
Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.

Other:
• Treatment as Usual (TAU)
Treatment as Usual (TAU) community treatment provided to the participant

Locations

Country	Name	City	State
United States	Treatment Research Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse	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.	6 months