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

Primary Purpose

Opiate Addiction

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Depot naltrexone

Treatment as Usual (TAU)

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring Depot naltrexone, Parolees, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Treatment Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Depot Naltrexone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00781898

First Posted

October 24, 2008

Last Updated

September 21, 2017

Sponsor

University of Pennsylvania

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00781898

Brief Title

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

Official Title

Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opiate Addiction

Keywords

Depot naltrexone, Parolees, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

308 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depot Naltrexone

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Depot naltrexone

Intervention Description

Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.

Intervention Type

Other

Intervention Name(s)

Treatment as Usual (TAU)

Intervention Description

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

Primary Outcome Measure Information:

Title

Relapse

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: