Diagnosis, Dual (Psychiatry)Phase 2NCT00237822
Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
A Phase 2 study testing Adherence Feedback (AF), AF + Contingency Management (AF + CM) and AF + Motivational Enhancement Therapy (AF + MET) in people with Diagnosis, Dual (Psychiatry) and Psychiatric Diagnosis, run by Yale University at 1 site in United States.
Trial summary
The investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly assigned to one of the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diagnosis, Dual (Psychiatry), Psychiatric Diagnosis, Drug Use Disorders
- What is being tested?
- Adherence Feedback (AF), AF + Contingency Management (AF + CM) and AF + Motivational Enhancement Therapy (AF + MET)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2007
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently being treated with any class of psychotropic medication
- Have used illicit drugs or abused prescription drugs within the past year
- Are not adhering completely to their medication
Who cannot join
- Current major depressive episode
- Active suicidal/homicidal ideation/intent
- Current manic episode
- Visiting nurse or living in a facility that distributed medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Substance Abuse Center
New Haven, Connecticut, 06519
About this study
Official title: Increasing Treatment Adherence in Co-Occurring Disorders
The investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided interventions following a 2-week "Assessment Only" baseline period:
- Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF, which is a procedure that represents a technological advancement developed by Cramer et al. (1989, 1995, and 1999) and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System (MEMS) caps,
- AF + Contingency Management (AF + CM); in this condition, participants will receive AF, as described above, PLUS contingency management. CM is based on the behavioral learning theory, which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded, or
- AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will receive AF, as described above, PLUS motivational enhancement therapy. MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence (i.e., reasons for and against changing/adhering), utilizing a series of strategies based on client-centered psychotherapy, self-efficacy theory, and social psychology.
Read more
The study will allow the evaluation of three hypotheses:
- AF + MET is superior to AF + CM,
- AF + MET is superior to AF alone, and
- AF + CM is superior to AF alone.
Primary outcome measures are:
- rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report,
- rates of counseling attendance, and
- reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report.
Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization. The investigators will also evaluate the relationship between adherence and primary and secondary outcomes.
- Being tested
- Adherence Feedback (AF), AF + Contingency Management (AF + CM), AF + Motivational Enhancement Therapy (AF + MET)
- Keywords
- Treatment Adherence, Co-Occurring Disorders, Motivational Enhancement Therapy, Contingency Management, MEMS Caps
- Medical subject headings
- Disease, Mental Disorders, Substance-Related Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence Feedback (AF)Behavioural
AF + Contingency Management (AF + CM)Behavioural
AF + Motivational Enhancement Therapy (AF + MET)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
Secondary outcomes (2)
Drug use
Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startSep 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, Dual (Psychiatry)Studies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Michael V. Pantalon, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237822
- Sponsor's protocol ID
- K23DA015144
- Other IDs
- K23DA015144
- Status last verified
- Oct 2005
- First submitted
- 7 Oct 2005
- Last updated
- 17 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Treatment Adherence in Co-Occurring Disorders
- ClinicalTrials.gov ID
- NCT00237822
- Acronym / sponsor ID
- K23DA015144
- Keywords
- Treatment Adherence, Co-Occurring Disorders, Motivational Enhancement Therapy, Contingency Management, MEMS Caps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2003
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Oct 2005 (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 investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided interventions following a 2-week "Assessment Only" baseline period:
- Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF, which is a procedure that represents a technological advancement developed by Cramer et al. (1989, 1995, and 1999) and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System (MEMS) caps,
- AF + Contingency Management (AF + CM); in this condition, participants will receive AF, as described above, PLUS contingency management. CM is based on the behavioral learning theory, which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded, or
- AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will receive AF, as described above, PLUS motivational enhancement therapy. MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence (i.e., reasons for and against changing/adhering), utilizing a series of strategies based on client-centered psychotherapy, self-efficacy theory, and social psychology.
The study will allow the evaluation of three hypotheses:
- AF + MET is superior to AF + CM,
- AF + MET is superior to AF alone, and
- AF + CM is superior to AF alone.
Primary outcome measures are:
- rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report,
- rates of counseling attendance, and
- reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report.
Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization. The investigators will also evaluate the relationship between adherence and primary and secondary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently being treated with any class of psychotropic medication
- Have used illicit drugs or abused prescription drugs within the past year
- Are not adhering completely to their medication
Key exclusion criteria (4 listed)
- Current major depressive episode
- Active suicidal/homicidal ideation/intent
- Current manic episode
- Visiting nurse or living in a facility that distributed medications
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 |
|---|---|---|
| Adherence Feedback (AF) | Behavioural | – |
| AF + Contingency Management (AF + CM) | Behavioural | – |
| AF + Motivational Enhancement Therapy (AF + MET) | Behavioural | – |
Primary outcome
Treatment adherence
2 secondary outcomes
Drug use
Depression
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 Oct 2017.
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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.
Michael V. Pantalon, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adherence Feedback (AF), AF + Contingency Management (AF + CM) and AF + Motivational Enhancement Therapy (AF + MET) in people with Diagnosis, Dual (Psychiatry) and Psychiatric Diagnosis, run by Yale 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 4 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 Oct 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment adherence. 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 Oct 2017.