Substance Use DisordersNCT01140334
Treatment for Psychological and Drug Abuse Problems
A study testing Voucher Reinforcement in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care. Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Voucher Reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Voluntarily seeking psychiatric treatment
- Meets DSM-IV criteria for opiate dependence
- Meets FDA/CSAT guidelines for methadone maintenance
- Meets DSM-IV criteria for at least one current psychiatric disorder
Who cannot join
- Pregnancy
- Onset or acute exacerbation of a medical illness requiring immediate and intense care
- An organic mental disorder (e.g., delirium, dementia)
- Current participation in psychiatric care
- Mandatory psychiatric treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Treatment Services
Baltimore, Maryland, 21224
About this study
Official title: Maximizing Effectiveness of Integrated Treatment Approaches
The purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care. Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist. Patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives. These incentives can be earned by successfully attending all scheduled psychiatric appointments each week. The investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.
Read the detailed description
Male and female opioid-dependent patients at Addiction Treatment Services with any current psychiatric disorder (N = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (ROIC), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (SOIC). Participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services. Participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention. Positive findings would have considerable heuristic and health care policy and practice implications. The entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.
- Conditions
- Substance Use Disorders
- Being tested
- Voucher Reinforcement, Standard Control
- Keywords
- Psychiatric adherence, Voucher incentives, Methadone treatment
- 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.
Voucher ReinforcementBehavioural
Patients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions. These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments. Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant. The maximum amount of voucher earnings over the study is $300.
Standard ControlBehavioural
Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. No voucher incentive will be offered in this condition.
| Study group | Role | What they receive |
|---|---|---|
| Reinforced On-Site Integrated Care (ROIC) | Experimental | Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance. Receives: Behavioral: Voucher Reinforcement |
| Standard On-Site Integrated Care (SOIC). | Active comparator | Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. Receives: Behavioral: Standard Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Treatment Adherence
Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.
Measured: Weekly for 12 weeks
Level of Psychiatric Distress
Patients will complete the Addiction Severity Index (ASI) and the SCL-90 every 4-weeks, for 12-weeks, to measure their current levels of psychiatric distress.
Measured: Every 4-weeks for 12 weeks
Secondary outcomes (3)
Psychiatric Medication Adherence
Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.
Measured: Every 4-weeks
Substance Use
Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).
Measured: Weekly for 12-weeks
Treatment Retention
The length of time subjects remain in treatment is tracked throughout the study.
Measured: Weekly for 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Kidorf, Johns Hopkins University
- Investigators
- Michael Kidorf, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140334
- Sponsor's protocol ID
- 1RC1DA028154-01
- Status last verified
- Sep 2013
- First submitted
- 3 Jun 2010
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kidorf M, Brooner RK, Gandotra N, Antoine D, King VL, Peirce J, Ghazarian S. Reinforcing integrated psychiatric service attendance in an opioid-agonist program: a randomized and controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):30-6. doi: 10.1016/j.drugalcdep.2013.06.005. Epub 2013 Jul 15.
PubMed 23866988
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Effectiveness of Integrated Treatment Approaches
- ClinicalTrials.gov ID
- NCT01140334
- Acronym / sponsor ID
- 1RC1DA028154-01
- Conditions
- Substance Use Disorders
- Keywords
- Psychiatric adherence, Voucher incentives, Methadone treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Jun 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 purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care. Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist. Patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives. These incentives can be earned by successfully attending all scheduled psychiatric appointments each week. The investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.
Detailed description
Male and female opioid-dependent patients at Addiction Treatment Services with any current psychiatric disorder (N = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (ROIC), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (SOIC). Participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services. Participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention. Positive findings would have considerable heuristic and health care policy and practice implications. The entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforced On-Site Integrated Care (ROIC) | Experimental | Behavioral: Voucher ReinforcementPatients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance. |
| Standard On-Site Integrated Care (SOIC). | Active comparator | Behavioral: Standard ControlPatients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Voluntarily seeking psychiatric treatment
- Meets DSM-IV criteria for opiate dependence
- Meets FDA/CSAT guidelines for methadone maintenance
- Meets DSM-IV criteria for at least one current psychiatric disorder
Key exclusion criteria (5 listed)
- Pregnancy
- Onset or acute exacerbation of a medical illness requiring immediate and intense care
- An organic mental disorder (e.g., delirium, dementia)
- Current participation in psychiatric care
- Mandatory psychiatric treatment
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 |
|---|---|---|
| Voucher ReinforcementPatients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions. These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments. Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant. The maximum amount of voucher earnings over the study is $300. | Behavioural | Reinforced On-Site Integrated Care (ROIC) |
| Standard ControlPatients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. No voucher incentive will be offered in this condition. | Behavioural | Standard On-Site Integrated Care (SOIC). |
Primary outcome
Psychiatric Treatment Adherence
Time frame: Weekly for 12 weeks
Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.
Level of Psychiatric Distress
Time frame: Every 4-weeks for 12 weeks
Patients will complete the Addiction Severity Index (ASI) and the SCL-90 every 4-weeks, for 12-weeks, to measure their current levels of psychiatric distress.
3 secondary outcomes
Psychiatric Medication Adherence
Time frame: Every 4-weeks
Substance Use
Time frame: Weekly for 12-weeks
Treatment Retention
Time frame: Weekly for 12-weeks
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 20 Sep 2013.
- Results publication: PubMed 23866988Kidorf M, Brooner RK, Gandotra N, Antoine D, King VL, Peirce J, Ghazarian S. Reinforcing integrated psychiatric service attendance in an opioid-agonist program: a randomized and controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):30-6. doi: 10.1016/j.drugalcdep.2013.06.005. Epub 2013 Jul 15.
Related trials for Substance Use Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
Michael Kidorf, Ph.D. principal investigator
Johns Hopkins 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 Voucher Reinforcement in people with Substance Use Disorders, run by Johns Hopkins 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 5 inclusion and 5 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 20 Sep 2013. 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?
Psychiatric Treatment Adherence (time frame: Weekly for 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140334, which also lists 1 linked publication.
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 20 Sep 2013.