Substance AbuseNCT03812484
An Evaluation of the NJSPB SCF Project for Opioid-Involved High-Risk Parolees
A study testing SCF Supervision and Parole-as-Usual in people with Substance Abuse and Criminal Behavior, run by Botec Analysis, LLC at 1 site in United States.
Trial summary
This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Criminal Behavior
- What is being tested?
- SCF Supervision and Parole-as-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older
- Participants must have a history of opioid use or addiction
- Participants have a history of parole violations or active parolees who are at risk for violation (this can include anyone who is reentering the active population from prison)
- Participants reside in or are moving to Ocean County; and
- Participants must have at least 6 months remaining on their Parole term
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
New Jersey Reentry Corporation
Toms River, New Jersey, 08753
About this study
Official title: An Evaluation of the New Jersey State Parole Board Swift, Certain, and Fair Project for Opioid-Involved High-Risk Parolees
This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).
Read the detailed description
The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program provides funding to states, units of local government, territories, and federally recognized Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public safety, foster collaboration, and to improve the outcomes of individuals under the supervision of community corrections. The goals of this program are to develop and enhance SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism and better outcomes for program participants. SCF approaches are intended to: (a) improve supervision strategies that reduce recidivism; (b) promote and increase collaboration among agencies and officials who work in community corrections and related fields to enhance swift and certain sanctions; (c) enhance the offenders' perception that the supervision decisions are fair, consistently applied, and consequences are transparent; and (d) improve the outcomes of individuals participating in these initiatives. The grantee will use awarded grant funds to support programming that provides services to up to 75 opioid involved parolees with services to divert them from a return to prison and manage underlying addictions with a combination of behavioral therapy and medication assisted treatments. The program combines sanctions with targeted reentry and treatment services.
- Conditions
- Substance Abuse, Criminal Behavior
- Being tested
- SCF Supervision, Parole-as-Usual
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCF SupervisionBehavioural
SCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing.
Parole-as-UsualBehavioural
Also called PAU
Parolees are supervised under standard parole supervision practice in New Jersey
| Study group | Role | What they receive |
|---|---|---|
| SCF Parole | Experimental | Parolee supervised under the SCF Supervision model Receives: Behavioral: SCF Supervision |
| Parole-As-Usual | Active comparator | Parolees are supervised under standard parole supervision practice in New Jersey. Receives: Behavioral: Parole-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revocation Rate
Percentage of subjects in each condition who are revoked from parole and returned to prison
Measured: 12 months
Secondary outcomes (3)
Days Incarcerated
Total number of days incarcerated in jail or prison
Measured: 12 months
New Charges
Number of new charges
Measured: 12 months
Percent Positive Drug Tests
Percentage of random and scheduled drug tests that test positive for illicit drugs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botec Analysis, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Clarissa Manning, Botec Analysis, LLC
- Investigators
- Clarissa Manning, MPP, Principal investigator, Botec Analysis, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812484
- Sponsor's protocol ID
- CC100
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the New Jersey State Parole Board Swift, Certain, and Fair Project for Opioid-Involved High-Risk Parolees
- ClinicalTrials.gov ID
- NCT03812484
- Acronym / sponsor ID
- CC100
- Conditions
- Substance Abuse, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Botec Analysis, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).
Detailed description
The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program provides funding to states, units of local government, territories, and federally recognized Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public safety, foster collaboration, and to improve the outcomes of individuals under the supervision of community corrections. The goals of this program are to develop and enhance SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism and better outcomes for program participants. SCF approaches are intended to: (a) improve supervision strategies that reduce recidivism; (b) promote and increase collaboration among agencies and officials who work in community corrections and related fields to enhance swift and certain sanctions; (c) enhance the offenders' perception that the supervision decisions are fair, consistently applied, and consequences are transparent; and (d) improve the outcomes of individuals participating in these initiatives. The grantee will use awarded grant funds to support programming that provides services to up to 75 opioid involved parolees with services to divert them from a return to prison and manage underlying addictions with a combination of behavioral therapy and medication assisted treatments. The program combines sanctions with targeted reentry and treatment services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCF Parole | Experimental | Behavioral: SCF SupervisionParolee supervised under the SCF Supervision model |
| Parole-As-Usual | Active comparator | Behavioral: Parole-as-UsualParolees are supervised under standard parole supervision practice in New Jersey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be 18 years of age or older
- Participants must have a history of opioid use or addiction
- Participants have a history of parole violations or active parolees who are at risk for violation (this can include anyone who is reentering the active population from prison)
- Participants reside in or are moving to Ocean County; and
- Participants must have at least 6 months remaining on their Parole term
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCF SupervisionSCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing. | Behavioural | SCF Parole |
| Parole-as-UsualAlso: PAUParolees are supervised under standard parole supervision practice in New Jersey | Behavioural | Parole-As-Usual |
Primary outcome
Revocation Rate
Time frame: 12 months
Percentage of subjects in each condition who are revoked from parole and returned to prison
3 secondary outcomes
Days Incarcerated
Time frame: 12 months
New Charges
Time frame: 12 months
Percent Positive Drug Tests
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarissa Manning, MPP principal investigator
Botec Analysis, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCF Supervision and Parole-as-Usual in people with Substance Abuse and Criminal Behavior, run by Botec Analysis, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revocation Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.