Opiate Addiction
Conditions
Keywords
Depot naltrexone, Parolees, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction
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.
Interventions
DRUGDepot naltrexone
Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
OTHERTreatment as Usual (TAU)
Treatment as Usual (TAU) community treatment provided to the participant
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse | 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. |
Countries
United States
Participant flow
Recruitment details
Community-dwelling adult volunteers who had been incarcerated and who had a history of opioid dependence.
Participants by arm
| Arm | Count |
|---|---|
| Depot Naltrexone Participants who were randomized to receive Extended Release Naltrexone | 153 |
| Placebo Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant | 155 |
| Total | 308 |
Baseline characteristics
| Characteristic | Placebo | Depot Naltrexone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 155 Participants | 153 Participants | 308 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 9.4 | 44 years STANDARD_DEVIATION 9.2 | 43.5 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 155 Participants | 153 Participants | 308 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 132 Participants | 129 Participants | 261 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 153 | 5 / 155 |
| other Total, other adverse events | 29 / 153 | 13 / 155 |
| serious Total, serious adverse events | 16 / 153 | 45 / 155 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depot Naltrexone | Relapse | 66 Participants |
| Placebo | Relapse | 99 Participants |