Substance AbusePhase 3Man TxNCT01372033
Effects of Manualized Treatment in a Seamless System
A Phase 3 study testing Cognitive Behavioral Therapy in people with Substance Abuse and Offenders, run by George Mason University at 1 site in United States.
Trial summary
The specific aims of this project are: 1. To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders; 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse, Offenders, Criminal Thinking
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2010
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Substance abusers
- men and women
- treatment
Who cannot join
- Parolees
- Low threshold substance abuse
- violent offenders
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Dvision of Parole and Probation
Baltimore, Maryland, 21221
About this study
Official title: Effects of Manualized Treatment in a Seamless System of Care: Handling Probation
The specific aims of this project are:
- To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders;
- To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level;
- To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and
- To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.
- Conditions
- Substance Abuse, Offenders, Criminal Thinking, HIV Risk Behaviors
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- drug treatment, substance abuse, offenders, high risk
- 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.
Cognitive Behavioral TherapyBehavioural
18 sessions of CBT, twice weekly
Cognitive Behavioral TherapyBehavioural
18 sessions with goals groups drug testing
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrest
Measured: 12 months
Secondary outcomes (1)
Treatment Completion
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 posted13 Jun 2011 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionDec 2010
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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Faye S Taxman, Ph.D., Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372033
- Sponsor's protocol ID
- R01DA017729
- Other IDs
- R01DA017729
- Acronym
- Man Tx
- Status last verified
- Jun 2009
- First submitted
- 10 Jun 2011
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manualized Treatment in a Seamless System of Care: Handling Probation
- ClinicalTrials.gov ID
- NCT01372033
- Acronym / sponsor ID
- Man Tx / R01DA017729
- Conditions
- Substance Abuse, Offenders, Criminal Thinking, HIV Risk Behaviors
- Keywords
- drug treatment, substance abuse, offenders, high risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jun 2011 (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 specific aims of this project are:
- To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders;
- To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level;
- To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and
- To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavioral TherapyUse of cognitive behavioral therapy focused on social skill development and interpersonal relationships |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Substance abusers
Key exclusion criteria (3 listed)
- Parolees
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 |
|---|---|---|
| Cognitive Behavioral Therapy18 sessions of CBT, twice weekly | Behavioural | CBT |
| Cognitive Behavioral Therapy18 sessions with goals groups drug testing | Behavioural | CBT |
Primary outcome
Arrest
Time frame: 12 months
1 secondary outcome
Treatment Completion
Time frame: 12 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 13 Jun 2011.
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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.
Faye S Taxman, Ph.D. principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy in people with Substance Abuse and Offenders, run by George Mason 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 3 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 13 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Arrest (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 13 Jun 2011.