Drugs of AbuseNCT01237691
An Evaluation of California's Experiment With HOPE
A study testing HOPE supervision and Parole-as-usual in people with Drugs of Abuse, run by Pepperdine University at 1 site in United States.
Trial summary
The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Drugs of Abuse
- What is being tested?
- HOPE 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
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assigned to the Sacramento Metro IV Parole Unit.
- Released from a term of return-to-custody for a violation for, or involving, the use of drugs.
- Have a maximum controlling discharge date at least one year from the date of release from the return-to-custody term.
Who cannot join
- History of convictions for crimes that require registration under Penal Code Section 290.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento Metro IV Parole Unit.
Sacramento, California, 95811
About this study
Official title: Phase 1 Study of California's HOPE Experiment
The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group.
Read the detailed description
The California HOPE pilot program is being implemented under the authority granted in Penal Code 5058.1. The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group compared with parole-as-usual.
- Conditions
- Drugs of Abuse
- Being tested
- HOPE supervision, Parole-as-usual
- Keywords
- drug use, drug arrests, incarceration
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE supervisionBehavioural
Also called HOPE, COPE
HOPE 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). HOPE includes regular random drug testing.
Parole-as-usualBehavioural
Also called Routine parole
Parolees are supervised under standard parole supervision practice in California.
| Study group | Role | What they receive |
|---|---|---|
| HOPE supervision | Experimental | Parolee supervised under California's new HOPE parole model. Receives: Behavioral: HOPE supervision |
| Parole-as-usual | Active comparator | Parolees supervised under California parole-as-usual. Receives: Behavioral: Parole-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days incarcerated
Total number of days incarcerated in jail or prison
Measured: 24 months
Secondary outcomes (5)
% positive drug tests
Percentage of random and scheduled drug tests that test positive for illicit drugs
Measured: 24 months
%Missed
Percentage of parole appointments that are missed.
Measured: 24 months
Revocation rate
Percentage of parolees that are revoked from probation and returned to prison for either a technical violation or on a new charge.
Measured: 24 months
New arrests
Number of new arrests.
Measured: 24 months
Perceptions of risk of detection
Parolees perceived risk of detection for drug use
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drugs of 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pepperdine University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Hawken, PhD, Principal investigator, Pepperdine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237691
- Sponsor's protocol ID
- SPPN1110F01
- Status last verified
- Apr 2018
- First submitted
- 1 Nov 2010
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of California's HOPE Experiment
- ClinicalTrials.gov ID
- NCT01237691
- Acronym / sponsor ID
- SPPN1110F01
- Conditions
- Drugs of Abuse
- Keywords
- drug use, drug arrests, incarceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Pepperdine UniversityUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of California, Los Angeles
- Study start
- Nov 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Nov 2010 (estimated)
- 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.
The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group.
Detailed description
The California HOPE pilot program is being implemented under the authority granted in Penal Code 5058.1. The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group compared with parole-as-usual.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE supervision | Experimental | Behavioral: HOPE supervisionParolee supervised under California's new HOPE parole model. |
| Parole-as-usual | Active comparator | Behavioral: Parole-as-usualParolees supervised under California parole-as-usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assigned to the Sacramento Metro IV Parole Unit.
- Released from a term of return-to-custody for a violation for, or involving, the use of drugs.
- Have a maximum controlling discharge date at least one year from the date of release from the return-to-custody term.
Key exclusion criteria (1 listed)
- History of convictions for crimes that require registration under Penal Code Section 290.
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 |
|---|---|---|
| HOPE supervisionAlso: HOPE, COPEHOPE 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). HOPE includes regular random drug testing. | Behavioural | HOPE supervision |
| Parole-as-usualAlso: Routine paroleParolees are supervised under standard parole supervision practice in California. | Behavioural | Parole-as-usual |
Primary outcome
Days incarcerated
Time frame: 24 months
Total number of days incarcerated in jail or prison
5 secondary outcomes
% positive drug tests
Time frame: 24 months
%Missed
Time frame: 24 months
Revocation rate
Time frame: 24 months
New arrests
Time frame: 24 months
Perceptions of risk of detection
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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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.
Angela Hawken, PhD principal investigator
Pepperdine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE supervision and Parole-as-usual in people with Drugs of Abuse, run by Pepperdine University 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 3 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: finished, as of the sponsor's last update on 10 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days incarcerated (time frame: 24 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 10 Apr 2018.