Bipolar DisorderNCT00167323
Early Recovery Adherence Therapy for Bipolar Alcoholics
A study testing Adherence therapy in people with Bipolar Disorder and Alcohol Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
Effective psychosocial interventions for individuals with an alcohol use disorder co-occurring with a severe mental health problem such as bipolar disorder are lacking. Treatment engagement, adherence, and retention are a major challenge and crucial to achieving a favorable outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Alcohol Use Disorder
- What is being tested?
- Adherence therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jul 2007
- 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
- Meet DSM-IV diagnostic criteria for Bipolar disorder and alcohol use disorder
- Actively abusing alcohol (drinking on 2 or more occasions per week or having 3 or more drinks per occasion)
- Have been stabilized on a mood stabilizer such as Valproate
- Absence of any exclusion criteria
Who cannot join
- Schizophrenia,, schizoaffective disorder or any psychotic disorder, unipolar major depression,, mental retardation, and signs of impaired cognitive functioning.
- Any severe or unstable neurological and medical condition including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome, severe cardiac, liver, kidney, endocrine, hematological, or impending surgery.
- Inability to read or understand the study forms and consent form
- Pregnancy
- The presence of non-alcohol substance use disorders will not constitute exclusion criteria unless it is clearly the drug of choice or it requires medications such as opioid substitution
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Effective psychosocial interventions for individuals with an alcohol use disorder co-occurring with a severe mental health problem such as bipolar disorder are lacking. Treatment engagement, adherence, and retention are a major challenge and crucial to achieving a favorable outcome. The early phase of recovery is a key period during which an effective intervention exerts its most significant impact. Our proposed treatment intervention is aimed at addressing early recovery issues, engagement, and treatment and medication adherence in bipolar alcoholics.
We propose to develop and refine a theoretically based and procedurally specified individual adherence therapy intervention for co-occurring alcohol use and bipolar disorder in early recovery, to develop standardized procedures, methods, and techniques so that treatment is delivered with a high degree of fidelity and competence, and to test the efficacy of this intervention through a randomized, parallel-group design comparing this new intervention with current regular clinical care.
Read the detailed description
Co-occurring alcoholism and bipolar disorder is a significant comorbid condition representing serious clinical challenges and treatment difficulties and is associated with severe disabilities, morbidity, and heightened risk for suicide. Despite the recent increased attention to the problem of psychiatric comorbidity with alcoholism and other substance use disorders, little research has been conducted on this complex form of comorbidity, especially in regard to effective treatment approaches.
Enhancing treatment engagement, adherence, and retention is perhaps the most challenging clinical concern faced by clinicians caring for this population. Poor adherence is a major clinical problem among bipolar disorder with alcoholism. Poor adherence is associated with substantial medical expenses and loss of productivity.
Factors interfering with treatment adherence range from access to treatment, to health care providers disposition towards these patients, and to symptoms related to both bipolar disorder and alcoholism. Enhancing motivation for treatment and improving treatment adherence are essential components for an initial treatment intervention for this population. Our proposed treatment intervention is based on the principles of Motivational Enhancement Therapy and also integrates psychosocial and pharmacotherapy interventions that have been successfully used with alcoholism and other addictive disorders. It is practical and easy to learn and administer in the framework of general clinical care by health professionals with varied educational backgrounds.
- Conditions
- Bipolar Disorder, Alcohol Use Disorder
- Being tested
- Adherence therapy
- Keywords
- Bipolar, Alcoholism
- Medical subject headings
- Bipolar Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The proposed intervention with have:
A higher rate of treatment completion,
A higher rate of treatment adherence as indicated by the number of sessions attended,
An improved outcome as indicated by a higher percentage of alcohol free days, less average number of drinks per drinking days, longer period to relapse to heavy alcohol use, and greater improvement in their manic or depressive symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Ihsan M Salloum, MD, MPH, Principal investigator, University of Pittsbugh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167323
- Sponsor's protocol ID
- 0307095
- Status last verified
- May 2008
- First submitted
- 9 Sep 2005
- Last updated
- 19 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recovery Adherence Therapy for Bipolar Alcoholics
- ClinicalTrials.gov ID
- NCT00167323
- Acronym / sponsor ID
- 0307095
- Conditions
- Bipolar Disorder, Alcohol Use Disorder
- Keywords
- Bipolar, Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Sep 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.
Effective psychosocial interventions for individuals with an alcohol use disorder co-occurring with a severe mental health problem such as bipolar disorder are lacking. Treatment engagement, adherence, and retention are a major challenge and crucial to achieving a favorable outcome. The early phase of recovery is a key period during which an effective intervention exerts its most significant impact. Our proposed treatment intervention is aimed at addressing early recovery issues, engagement, and treatment and medication adherence in bipolar alcoholics.
We propose to develop and refine a theoretically based and procedurally specified individual adherence therapy intervention for co-occurring alcohol use and bipolar disorder in early recovery, to develop standardized procedures, methods, and techniques so that treatment is delivered with a high degree of fidelity and competence, and to test the efficacy of this intervention through a randomized, parallel-group design comparing this new intervention with current regular clinical care.
Detailed description
Co-occurring alcoholism and bipolar disorder is a significant comorbid condition representing serious clinical challenges and treatment difficulties and is associated with severe disabilities, morbidity, and heightened risk for suicide. Despite the recent increased attention to the problem of psychiatric comorbidity with alcoholism and other substance use disorders, little research has been conducted on this complex form of comorbidity, especially in regard to effective treatment approaches.
Enhancing treatment engagement, adherence, and retention is perhaps the most challenging clinical concern faced by clinicians caring for this population. Poor adherence is a major clinical problem among bipolar disorder with alcoholism. Poor adherence is associated with substantial medical expenses and loss of productivity.
Factors interfering with treatment adherence range from access to treatment, to health care providers disposition towards these patients, and to symptoms related to both bipolar disorder and alcoholism. Enhancing motivation for treatment and improving treatment adherence are essential components for an initial treatment intervention for this population. Our proposed treatment intervention is based on the principles of Motivational Enhancement Therapy and also integrates psychosocial and pharmacotherapy interventions that have been successfully used with alcoholism and other addictive disorders. It is practical and easy to learn and administer in the framework of general clinical care by health professionals with varied educational backgrounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet DSM-IV diagnostic criteria for Bipolar disorder and alcohol use disorder
- Actively abusing alcohol (drinking on 2 or more occasions per week or having 3 or more drinks per occasion)
- Have been stabilized on a mood stabilizer such as Valproate
- Absence of any exclusion criteria
Key exclusion criteria (5 listed)
- Schizophrenia,, schizoaffective disorder or any psychotic disorder, unipolar major depression,, mental retardation, and signs of impaired cognitive functioning.
- Any severe or unstable neurological and medical condition including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome, severe cardiac, liver, kidney, endocrine, hematological, or impending surgery.
- Inability to read or understand the study forms and consent form
- Pregnancy
- The presence of non-alcohol substance use disorders will not constitute exclusion criteria unless it is clearly the drug of choice or it requires medications such as opioid substitution
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 therapy | Behavioural | – |
Primary outcome
The proposed intervention with have:
A higher rate of treatment completion,
A higher rate of treatment adherence as indicated by the number of sessions attended,
An improved outcome as indicated by a higher percentage of alcohol free days, less average number of drinks per drinking days, longer period to relapse to heavy alcohol use, and greater improvement in their manic or depressive symptoms
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 19 May 2008.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Ihsan M Salloum, MD, MPH principal investigator
University of Pittsbugh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence therapy in people with Bipolar Disorder and Alcohol Use Disorder, run by University of Pittsburgh 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 4 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 19 May 2008. 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?
The proposed intervention with have:. The study lists 4 primary outcomes in all. 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 19 May 2008.