Opioid Dependence
Conditions
Keywords
opioid dependence, VIVITROL, criminal justice
Brief summary
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
Detailed description
This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.
Interventions
DRUGVIVITROL 380mg
380 mg IM injection given once monthly
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence * Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening * Expressing a goal of opiate-free treatment upon release * Currently opioid free * Planning to live in the Baltimore, MD area for at least 8 months following prison release
Exclusion criteria
* Pregnancy and/or breastfeeding * Clinically significant active medical condition * Active hepatitis * Past or present history of an AIDS-indicator disease in subjects who are infected with HIV * Any untreated or unstable psychiatric disorder(eg, bipolar with mania) * Recent suicidal ideation * Current chronic pain diagnosis for which opioids are prescribed * Positive drug test for opioids * History of drug overdose within the past 3 years requiring inpatient hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Subject Re-arrest | 7 months | Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | 7 months | Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test. |
| Opioid Overdose | 7 months | Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times. |
| Drug Abuse Treatment Program Entry | 7 months | Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form. |
| Retention in the Community | 6 months | Number of subjects who received all 6 post-release VIVITROL injections |
| Incidence of Subject Re-incarceration | 7 months | Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report. |
| Opioid Dependence | 7 months | Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence |
| Cocaine Use | 6 months | Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests |
| Criminal Activity | 6 months | Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires |
| Opioid Craving | 8 months | Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever. |
Countries
United States
Participant flow
Recruitment details
Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (3 for men and 1 for women) received 1 injection of VIVITROL prior to release from prison and were offered 6 monthly injections of VIVITROL after release from prison, for a total of 7 injections.
Pre-assignment details
Eligible subjects had a diagnosis of opioid dependence, were seeking treatment, and were eligible for release from prison within 30 days from screening.
Participants by arm
| Arm | Count |
|---|---|
| VIVITROL 380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Incarcerated | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | VIVITROL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 39.9 Years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 27 |
| serious Total, serious adverse events | 6 / 27 |
Outcome results
Primary
Incidence of Subject Re-arrest
Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.
Time frame: 7 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Incidence of Subject Re-arrest | 6 participants re-arrested |
| All 7 Injections | Incidence of Subject Re-arrest | 2 participants re-arrested |
p-value: >0.05Fisher Exact
Secondary
Cocaine Use
Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
Time frame: 6 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Cocaine Use | 5 participants who used cocaine |
| All 7 Injections | Cocaine Use | 0 participants who used cocaine |
p-value: <0.1Fisher Exact
Secondary
Criminal Activity
Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires
Time frame: 6 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Criminal Activity | 18 participants with criminal activity |
Secondary
Drug Abuse Treatment Program Entry
Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.
Time frame: 7 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Drug Abuse Treatment Program Entry | 24 participants who entered drug treatment |
Secondary
Incidence of Subject Re-incarceration
Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.
Time frame: 7 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Incidence of Subject Re-incarceration | 5 participants re-incarcerated |
| All 7 Injections | Incidence of Subject Re-incarceration | 2 participants re-incarcerated |
p-value: >0.05Fisher Exact
Secondary
Opioid Craving
Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.
Time frame: 8 months
Population: All subjects with non-missing data who received at least 1 injection of VIVITROL
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| <7 Injections | Opioid Craving | Actual Value | 21.0 units on a scale | Standard Deviation 33.4 |
| <7 Injections | Opioid Craving | Change from Baseline | -11.0 units on a scale | Standard Deviation 47.4 |
Secondary
Opioid Dependence
Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Time frame: 7 months
Secondary
Opioid Overdose
Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times.
Time frame: 7 months
Population: All subjects who received at least 1 injection of VIVITROL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Opioid Overdose | 1 participants who overdosed |
Secondary
Opioid Use
Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
Time frame: 7 months
Population: All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Opioid Use | 11 participants with positive opioid use |
| All 7 Injections | Opioid Use | 2 participants with positive opioid use |
p-value: <0.05Fisher Exact
Secondary
Retention in the Community
Number of subjects who received all 6 post-release VIVITROL injections
Time frame: 6 months
Population: All subjects who received at least 1 injection of VIVITROL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <7 Injections | Retention in the Community | 10 participants received all 7 injections |