Substance AbusePhase 1NCT00350571
Brief Interventions for Drop-out Re-engagement
A Phase 1 study testing brief (behavioral therapy) and Drop out re-engagement motivational intervention in people with Substance Abuse, run by Yale University at 2 sites in United States.
Trial summary
We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- brief (behavioral therapy) and Drop out re-engagement motivational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Nov 2009
- Phase
- Phase 1
- 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
- admission to outpatient treatment
Who cannot join
- need for hospitalization
Trial locations and contacts
2 sites in 1 country.
United States2 sites
APT Foundation
New Haven, Connecticut, 06510
Connecticut Mental Health Center
New Haven, Connecticut, 06510
About this study
Official title: Adaptive Brief Interventions for Drop-out Re-engagement
We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.
Read the detailed description
We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.
- Conditions
- Substance Abuse
- Being tested
- brief (behavioral therapy), Drop out re-engagement motivational intervention, standard care follow up
- Keywords
- behavior therapy, counseling, drug abuse therapy, outpatient care, therapy compliance, clinical trial phase I, coping, outcomes research, satisfaction, social psychology, patient oriented research
- Medical subject headings
- Substance-Related Disorders, Patient Compliance, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief (behavioral therapy)Behavioural
up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.
Drop out re-engagement motivational interventionBehavioural
Up to 3 phone or office based counseling sessions to promote reengagement in treatment
standard care follow upBehavioural
routine counselor phone calls and letters
| Study group | Role | What they receive |
|---|---|---|
| Standard care follow up | Active comparator | Standard care counselor follow up care phone calls or letters. Receives: Behavioral: standard care follow up |
| Drop out reengagement motivational intervention | Experimental | Single session office based or phone based motivational counseling session designed to promote participant re-engagement in standard treatment. Receives: Behavioral: brief (behavioral therapy); Behavioral: Drop out re-engagement motivational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention into outpatient treatment
Measured: 4, 8, 12, 24 weeks
Secondary outcomes (2)
substance abuse
Measured: 4, 8,12,and 24 weeks
psychiatric symptoms
Measured: 4, 8, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startNov 2004
- Primary completionNov 2009
- Study completionNov 2009
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.
- More trials run by Yale 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Ball, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350571
- Sponsor's protocol ID
- 101010101
- Other IDs
- 5P50DA009241-120012, 5P50DA009241
- Status last verified
- Sep 2014
- First submitted
- 7 Jul 2006
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Brief Interventions for Drop-out Re-engagement
- ClinicalTrials.gov ID
- NCT00350571
- Acronym / sponsor ID
- 101010101
- Conditions
- Substance Abuse
- Keywords
- behavior therapy, counseling, drug abuse therapy, outpatient care, therapy compliance, clinical trial phase I, coping, outcomes research
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Jul 2006 (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.
We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.
Detailed description
We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care follow up | Active comparator | Behavioral: standard care follow upStandard care counselor follow up care phone calls or letters. |
| Drop out reengagement motivational intervention | Experimental | Behavioral: brief (behavioral therapy), Behavioral: Drop out re-engagement motivational interventionSingle session office based or phone based motivational counseling session designed to promote participant re-engagement in standard treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admission to outpatient treatment
Key exclusion criteria (1 listed)
- need for hospitalization
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 |
|---|---|---|
| brief (behavioral therapy)up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment. | Behavioural | Drop out reengagement motivational intervention |
| Drop out re-engagement motivational interventionUp to 3 phone or office based counseling sessions to promote reengagement in treatment | Behavioural | Drop out reengagement motivational intervention |
| standard care follow uproutine counselor phone calls and letters | Behavioural | Standard care follow up |
Primary outcome
retention into outpatient treatment
Time frame: 4, 8, 12, 24 weeks
2 secondary outcomes
substance abuse
Time frame: 4, 8,12,and 24 weeks
psychiatric symptoms
Time frame: 4, 8, 12, and 24 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 17 Sep 2014.
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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.
Sam Ball, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing brief (behavioral therapy) and Drop out re-engagement motivational intervention in people with Substance Abuse, run by Yale University at 2 sites 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 1 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 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
retention into outpatient treatment (time frame: 4, 8, 12, 24 weeks). 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 17 Sep 2014.