Drug AddictionPhase 3NCT01003496
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
A Phase 3 study testing Treatment as Usual (TAU) and TAU + Long-Term Recovery Management in people with Drug Addiction, run by Wright State University at 1 site in United States.
Trial summary
The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Treatment as Usual (TAU) and TAU + Long-Term Recovery Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2009to 27 Jul 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, a subject must:
- At least 18 years of age
- Meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). Persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification
- Self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at Maryhaven
- Willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions).
Who cannot join
- Potential subjects will be excluded if they: 1) present with current suicide risk
- Have a current, untreated psychotic disorder
- Plan to relocate outside of the area within 12 months
- Have been sentenced to incarceration of more than 30 days over the next 6 months
- Are alcohol dependent without current dependence on cocaine or opioids.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).
Read the detailed description
Drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. Despite this, substance abuse treatment has traditionally been based on an acute care model. The field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response.
In response to these needs we have developed the Long Term Recovery Management (LTRM) model. LTRM is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. LTRM combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. The LTRM model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.
- Conditions
- Drug Addiction
- Being tested
- Treatment as Usual (TAU), TAU + Long-Term Recovery Management
- Keywords
- Cocaine, crack, heroin, non-prescribed opioids, contingency management, community reinforcement approach, facilitated therapeutic alliance, chronic disease treatment models
- 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.
Treatment as Usual (TAU)Behavioural
Outpatient substance abuse treatment
TAU + Long-Term Recovery ManagementBehavioural
Long-Term Recovery Management (LTRM) combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. Patients randomly assigned to LTRM will be asked to participate in group sessions each month for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Not described Receives: Behavioral: Treatment as Usual (TAU) |
| TAU + Long-Term Recovery Management (LTRM) | Experimental | Not described Receives: Behavioral: TAU + Long-Term Recovery Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is weeks of abstinence from the primary drug of dependence.
Measured: 12 months
Secondary outcomes (1)
Secondary outcomes include drug-free days and reduction in HIV risk behaviors.
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 posted28 Oct 2009 (estimated)
- Study start5 Nov 2009
- Primary completion27 Jul 2011
- Study completion27 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryhaven, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Robert G Carlson, Ph.D., Principal investigator, Wright State University Boonshoft School of MedicineRussel Falck, MA, Study director, Wright State University Boonshoft School of MedicineGregory Brigham, Ph.D., Study director, MaryhavenBrenda M Booth, Ph.D., Study director, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003496
- Sponsor's protocol ID
- NIDA/NIH 1RC1DA028467-01
- Other IDs
- 1RC1DA028467-01
- Status last verified
- Feb 2022
- First submitted
- 27 Oct 2009
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01003496
- Acronym / sponsor ID
- NIDA/NIH 1RC1DA028467-01
- Conditions
- Drug Addiction
- Keywords
- Cocaine, crack, heroin, non-prescribed opioids, contingency management, community reinforcement approach, facilitated therapeutic alliance, chronic disease treatment models
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryhaven, University of Arkansas
- Study start
- 5 Nov 2009 (actual)
- Primary completion
- 27 Jul 2011 (actual)
- Study completion
- 27 Jul 2011 (actual)
- First posted
- 28 Oct 2009 (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 this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).
Detailed description
Drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. Despite this, substance abuse treatment has traditionally been based on an acute care model. The field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response.
In response to these needs we have developed the Long Term Recovery Management (LTRM) model. LTRM is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. LTRM combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. The LTRM model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU) |
| TAU + Long-Term Recovery Management (LTRM) | Experimental | Behavioral: TAU + Long-Term Recovery Management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). Persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification
- Self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at Maryhaven
- Willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions).
Key exclusion criteria (5 listed)
- Potential subjects will be excluded if they: 1) present with current suicide risk
- Have a current, untreated psychotic disorder
- Plan to relocate outside of the area within 12 months
- Have been sentenced to incarceration of more than 30 days over the next 6 months
- Are alcohol dependent without current dependence on cocaine or opioids.
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 |
|---|---|---|
| Treatment as Usual (TAU)Outpatient substance abuse treatment | Behavioural | Treatment as Usual (TAU) |
| TAU + Long-Term Recovery ManagementLong-Term Recovery Management (LTRM) combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. Patients randomly assigned to LTRM will be asked to participate in group sessions each month for 12 months. | Behavioural | TAU + Long-Term Recovery Management (LTRM) |
Primary outcome
The main outcome is weeks of abstinence from the primary drug of dependence.
Time frame: 12 months
1 secondary outcome
Secondary outcomes include drug-free days and reduction in HIV risk behaviors.
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 9 Mar 2022.
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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.
Robert G Carlson, Ph.D. principal investigator
Wright State University Boonshoft School of Medicine
Russel Falck, MA study director
Wright State University Boonshoft School of Medicine
Gregory Brigham, Ph.D. study director
Maryhaven
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 Treatment as Usual (TAU) and TAU + Long-Term Recovery Management in people with Drug Addiction, run by Wright State 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 9 Mar 2022. 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?
The main outcome is weeks of abstinence from the primary drug of dependence. (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 9 Mar 2022.