Opiate Dependence
Conditions
Keywords
Extended-release naltrexone, Prisoners, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction
Brief summary
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
Detailed description
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.
Interventions
380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
BEHAVIORALMotivational Enhancement Counseling
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Sponsors
Alkermes, Inc.
New York City Department of Health and Mental Hygiene
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults incarcerated in NYC jails with known release date * DSM-IV criteria for current opioid dependence * No current agonist (methadone, buprenorphine) treatment * Currently opioid free by history ('detoxed') and with a negative urine for all opioids * General good health as determined by complete medical interview and physical examination * Age 18-60 years.
Exclusion criteria
* History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal * Pregnancy, lactation, or planning conception * Active medical illness that might make participation hazardous * Untreated psychiatric disorder * History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent. * Current chronic pain condition treated with opioids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Release Opioid Relapse | Four weeks post-release | Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation in Community Drug Treatment Post-release | Four weeks post-release | This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit. |
| Any Opioid Use Post-release | Four weeks post-release | Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release. |
| Injection Drug Use Post-release | Four weeks post-release | This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail. |
| Accidental Drug Overdose | Four weeks post-release | Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs. |
| Adverse Events and Serious Adverse Events | Eight weeks post-release | AEs and SAEs per standard definitions will be measured by self-report. |
Countries
United States
Participant flow
Recruitment details
Recruitment of participants took place at NYC jail medical clinics (Rikers Island; EMTC, RMSC) with follow-up visits taking place at Bellevue Hospital. The last participant completed in June 2013.
Pre-assignment details
Of the 48 consented participants enrolled into study between January 2010-May 2013, 34 were randomized into one of two trial arms, with n=17 to Extended-Release Naltrexone arm and n=17 to the Motivational Enhancement Counseling Only arm (treatment-as-usual).
Participants by arm
| Arm | Count |
|---|---|
| Extended-release Naltrexone (XR-NTX) A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). | 16 |
| Motivational Enhancement Counseling Only The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
Baseline characteristics
| Characteristic | Motivational Enhancement Counseling Only | Extended-release Naltrexone (XR-NTX) | 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 | 17 Participants | 16 Participants | 33 Participants |
| Age, Continuous | 47 years | 40 years | 44 years |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 16 | 1 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Post-Release Opioid Relapse
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
Time frame: Four weeks post-release
Population: One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Post-Release Opioid Relapse | 6 participants |
| Motivational Enhancement Counseling Only | Post-Release Opioid Relapse | 15 participants |
Secondary
Accidental Drug Overdose
Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
Time frame: Four weeks post-release
Population: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Accidental Drug Overdose | 0 participants |
| Motivational Enhancement Counseling Only | Accidental Drug Overdose | 0 participants |
Secondary
Adverse Events and Serious Adverse Events
AEs and SAEs per standard definitions will be measured by self-report.
Time frame: Eight weeks post-release
Population: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Adverse Events and Serious Adverse Events | 5 participants |
| Motivational Enhancement Counseling Only | Adverse Events and Serious Adverse Events | 1 participants |
Secondary
Any Opioid Use Post-release
Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.
Time frame: Four weeks post-release
Population: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Any Opioid Use Post-release | 17 percentage of participants |
| Motivational Enhancement Counseling Only | Any Opioid Use Post-release | 82 percentage of participants |
Secondary
Injection Drug Use Post-release
This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.
Time frame: Four weeks post-release
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Injection Drug Use Post-release | 25 percentage of participants by arm |
| Motivational Enhancement Counseling Only | Injection Drug Use Post-release | 6 percentage of participants by arm |
Secondary
Participation in Community Drug Treatment Post-release
This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.
Time frame: Four weeks post-release
Population: One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-release Naltrexone (XR-NTX) | Participation in Community Drug Treatment Post-release | 19 percentage of participants |
| Motivational Enhancement Counseling Only | Participation in Community Drug Treatment Post-release | 12 percentage of participants |