Trial Outcomes & Findings for A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration (NCT NCT01453374)
NCT ID: NCT01453374
Last Updated: 2015-07-13
Results Overview
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.
COMPLETED
PHASE4
27 participants
7 months
2015-07-13
Participant Flow
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.
Eligible subjects had a diagnosis of opioid dependence, were seeking treatment, and were eligible for release from prison within 30 days from screening.
Participant milestones
| Measure |
VIVITROL
380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
VIVITROL
380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Incarcerated
|
2
|
Baseline Characteristics
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Baseline characteristics by cohort
| Measure |
VIVITROL
n=27 Participants
380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
39.9 Years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
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.
Outcome measures
| Measure |
<7 Injections
n=16 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
n=10 Participants
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Incidence of Subject Re-arrest
|
6 participants re-arrested
|
2 participants re-arrested
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
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.
Outcome measures
| Measure |
<7 Injections
n=16 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
n=10 Participants
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Incidence of Subject Re-incarceration
|
5 participants re-incarcerated
|
2 participants re-incarcerated
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data
Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
Outcome measures
| Measure |
<7 Injections
n=16 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
n=10 Participants
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Opioid Use
|
11 participants with positive opioid use
|
2 participants with positive opioid use
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: All subjects who received at least 1 injection of VIVITROL
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.
Outcome measures
| Measure |
<7 Injections
n=27 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Opioid Overdose
|
1 participants who overdosed
|
—
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.
Outcome measures
| Measure |
<7 Injections
n=26 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Drug Abuse Treatment Program Entry
|
24 participants who entered drug treatment
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects who received at least 1 injection of VIVITROL
Number of subjects who received all 6 post-release VIVITROL injections
Outcome measures
| Measure |
<7 Injections
n=27 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Retention in the Community
|
10 participants received all 7 injections
|
—
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL
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.
Outcome measures
| Measure |
<7 Injections
n=24 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Opioid Craving
Change from Baseline
|
-11.0 units on a scale
Standard Deviation 47.4
|
—
|
|
Opioid Craving
Actual Value
|
21.0 units on a scale
Standard Deviation 33.4
|
—
|
SECONDARY outcome
Timeframe: 7 monthsMeeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL
Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
Outcome measures
| Measure |
<7 Injections
n=13 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
n=9 Participants
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Cocaine Use
|
5 participants who used cocaine
|
0 participants who used cocaine
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data
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
Outcome measures
| Measure |
<7 Injections
n=26 Participants
Subjects who received less than 7 VIVITROL injections
|
All 7 Injections
Subjects who received all 7 VIVITROL injections
|
|---|---|---|
|
Criminal Activity
|
18 participants with criminal activity
|
—
|
Adverse Events
VIVITROL
Serious adverse events
| Measure |
VIVITROL
n=27 participants at risk
380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly
|
|---|---|
|
Immune system disorders
Anaphylactic reaction
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Immune system disorders
Hypersensitivity
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Infections and infestations
Abscess limb
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Psychotic disorder
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.7%
1/27 • Number of events 1 • Data were collected during a 9-month time frame
|
Other adverse events
| Measure |
VIVITROL
n=27 participants at risk
380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
14.8%
4/27 • Number of events 5 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • Number of events 7 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.8%
4/27 • Number of events 6 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Gastrointestinal disorders
Toothache
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
General disorders
Oedema peripheral
|
14.8%
4/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
General disorders
Chest pain
|
11.1%
3/27 • Number of events 6 • Data were collected during a 9-month time frame
|
|
General disorders
Injection site nodule
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
General disorders
Pain
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
General disorders
Injection site pain
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Infections and infestations
Urinary tract infection
|
14.8%
4/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Injury, poisoning and procedural complications
Laceration
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Investigations
Blood glucose increased
|
18.5%
5/27 • Number of events 5 • Data were collected during a 9-month time frame
|
|
Investigations
Platelet count increased
|
18.5%
5/27 • Number of events 5 • Data were collected during a 9-month time frame
|
|
Investigations
Urine analysis abnormal
|
14.8%
4/27 • Number of events 5 • Data were collected during a 9-month time frame
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
CSF specific gravity increased
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
Haemoglobin decreased
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
Urine ketone body present
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
Weight decreased
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
White blood cell decreased
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Investigations
Haematocrit decreased
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.8%
4/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
2/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.4%
2/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Nervous system disorders
Headache
|
18.5%
5/27 • Number of events 6 • Data were collected during a 9-month time frame
|
|
Nervous system disorders
Dizziness
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Depression
|
29.6%
8/27 • Number of events 10 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Anxiety
|
14.8%
4/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Stress
|
14.8%
4/27 • Number of events 4 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Suicidal ideation
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Agitation
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Drug withdrawal syndrome
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
44.4%
12/27 • Number of events 14 • Data were collected during a 9-month time frame
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
3/27 • Number of events 5 • Data were collected during a 9-month time frame
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.4%
2/27 • Number of events 2 • Data were collected during a 9-month time frame
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
3/27 • Number of events 3 • Data were collected during a 9-month time frame
|
|
Vascular disorders
Hypertension
|
40.7%
11/27 • Number of events 13 • Data were collected during a 9-month time frame
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of such disclosure must be given to Alkermes for review at least 60 days prior to submission for publication. Revision to such disclosure will be negotiated in good faith by the Institution, Principal Investigator, and Alkermes. The disclosure may be submitted for publication or presented by the Institution and Principal Investigator only following receipt of written notice from an authorized representative of Alkermes stating that the disclosure has been reviewed and approved.
- Publication restrictions are in place
Restriction type: OTHER