AlcoholismPhase 4NCT00261872
Treatment of Patients With Alcoholism and Attention Deficit Disorder
A Phase 4 study testing Methylphenidate in people with Alcoholism and Attention Deficit Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study of persons with both alcoholism and ADHD will determine whether adding the drug methylphenidate to a standard treatment program will decrease alcohol use. In approximately half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is associated with a significantly increased… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcoholism, Attention Deficit Disorder
- What is being tested?
- Methylphenidate
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2005to 9 Apr 2007
- Phase
- Phase 4
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 or older.
- DSM-IV diagnosis of alcohol dependence or alcohol abuse on SCID, and alcohol problems as primary complaint among SUD:s
- DSM-IV diagnosis of ADHD on SCID, confirmed by CAARS-INV
Who cannot join
- General exclusion criteria for the NIAAA intramural treatment program:
- People who present with complicated medical problems requiring intensive medical or diagnostic management, such as hypertensive emergency, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease.
- People who are infected with the Human Immunodeficiency Virus (HIV).
- Serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment, such as psychotic illness or severe dementia (incompetent individuals).
- People who are unlikely or unable to complete the treatment program because they become or are likely to be incarcerated while on the protocol.
- People who are required to receive treatment by a court of law or who are involuntarily committed to treatment.
Show all 25Show fewer
- People with uncontrolled hypertension
- People with a history of withdrawal seizures
- Study specific exlusion criteria:
- Pregnancy or lactation (negative pregnancy test required)
- Use of psychotropic medication (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) within last 4 weeks, except when given within the program as part of medically supervised withdrawal. Use of these medications constitutes prima facie evidence of general exclusion category 3 (above). Persons identified with psychiatric conditions deemed exclusionary will be referred to community resources for inpatient or outpatient treatment as indicated. Persons with acute psychiatric emergencies (e.g. bipolar disorder, manic phase, significant depressive symptoms, or active suicidal ideation) will be referred for immediate care to ensure safety and stabilization; such actions will be appropriately documented.
- Past DSM-IV diagnosis of dependence (but not abuse, or reported occasional use of) drugs of abuse other than alcohol.
- Present DSM-IV diagnosis (but not sporadic use) of dependence on any central stimulant
- Present use of guanethidine or yohimbine
- Contraindications / warnings for naltrexone (in addition to those included in the general exclusion criteria):
- 1. known supersensitivity to the drug
- 2. acute hepatitis (any transaminase great than 3 x upper normal interval limit)
- 3. ongoing (within last month) use of opid analgesics, or illicit opiates
- 7. Contraindications / warnings for methylphenidate (in addition to those included in the general exclusion criteria):
- known supersensitivity to the drug
- marked anxiety, tension or agitation, since the drug may aggravate these symptoms
- glaucoma
- motor tics, or family history or diagnosis of Tourettes syndrome
- history of seizures
- hypertension, or known disease which can be aggravated by an elevation of blood pressure or increased pulse rate
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study of persons with both alcoholism and ADHD will determine whether adding the drug methylphenidate to a standard treatment program will decrease alcohol use. In approximately half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is associated with a significantly increased incidence of substance use disorder. Also, more than one-third of adults with substance use disorder have symptoms of ADHD. This study will evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program in improving patients' treatment compliance and decreasing adverse consequences of drinking, as well as monitoring their attention deficit/hyperactivity symptoms,
People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder (ADHD) may be eligible for this study.
Read more
Participants are randomly assigned to receive either slow-release methylphenidate (an approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol treatment program, which includes a standardized 12-week behavioral therapy course and treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week with the standard NIAAA treatment evaluation battery, including:
- Timeline Followback: A validated self-report method to assess a person's drinking over a defined interval in time
- Addiction Severity Index: A validated interview that measures problem severity in seven areas related to drug and alcohol abuse
- Biomarkers for alcohol abuse
- Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)
Read the detailed description
Background: Several pharmacological therapies for relapse prevention in alcoholism have now been documented for efficacy. A key issue that has emerged is the role of patient compliance with medication in mediating efficacy. Psychological traits common among alcoholics interact with treatment compliance. Thus, a considerable proportion of alcoholics, e.g. more than one third of treatment seeking populations, display signs and symptoms of adult ADHD. The impaired ability for long term planning and sustained goal-oriented behaviors in this group is likely to impair compliance with pharmacological treatment, thus reducing its potential beneficial effects.
Well documented pharmacological treatments are also available for ADHD. Among these, methylphenidate has a strong documentation, and has been demonstrated to be as efficacious in adult ADHD as in the childhood condition. A recently introduced slow release preparation of methylphenidate appears to offer considerable advantages, in that it eliminates most of the abuse potential, and allows once daily administration.
Aims: The aim of this study is to evaluate whether addition of methylphenidate to a state of the art treatment program for alcohol dependence will improve clinically relevant treatment outcomes such as validated measures of alcohol drinking.
Methods: The hypothesis will be addressed in a 12 week randomized, placebo controlled double blind add-on trial. Participation will be offered to subjects with alcohol dependence, aged 21-65 years, who enter the NIAAA alcohol treatment program, do not have any severe psychiatric or physical morbidity, and meet criteria for adult ADHD. All patients who are included will be given a standardized state of the art 12 week behavioral treatment package, as well as naltexone, an approved medication for relapse prevention. In addition subjects will be randomized to slow release methylphenidate or corresponding placebo. Patients will be evaluated upon weekly visits using the standard NIAAA treatment evaluation battery TLFB, ASI, biomarkers, as well as the established CAARS rating scale for attention deficit / hyperactivity. Primary outcome will be measures of drinking obtained by the TLFB methodology. Secondary outcomes will measures of attention deficit and hyperactivity, as measured by the CAARS scores.
- Conditions
- Alcoholism, Attention Deficit Disorder
- Being tested
- Methylphenidate
- Keywords
- Alcoholism, Attention Deficit Disorder, ADHD
- Medical subject headings
- Alcoholism, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study start1 Dec 2005
- Study completion9 Apr 2007
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 AlcoholismStudies 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 4
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261872
- Sponsor's protocol ID
- 060004
- Other IDs
- 06-AA-0004
- Status last verified
- 9 Apr 2007
- First submitted
- 3 Dec 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions for alcohol dependence (the COMBINE study): a pilot feasibility study. Alcohol Clin Exp Res. 2003 Jul;27(7):1123-31. doi: 10.1097/01.ALC.0000078020.92938.0B.
PubMed 12878918
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Alcoholism and Attention Deficit Disorder
- ClinicalTrials.gov ID
- NCT00261872
- Acronym / sponsor ID
- 060004
- Conditions
- Alcoholism, Attention Deficit Disorder
- Keywords
- Alcoholism, Attention Deficit Disorder, ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 1 Dec 2005
- Study completion
- 9 Apr 2007
- First posted
- 5 Dec 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.
This study of persons with both alcoholism and ADHD will determine whether adding the drug methylphenidate to a standard treatment program will decrease alcohol use. In approximately half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is associated with a significantly increased incidence of substance use disorder. Also, more than one-third of adults with substance use disorder have symptoms of ADHD. This study will evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program in improving patients' treatment compliance and decreasing adverse consequences of drinking, as well as monitoring their attention deficit/hyperactivity symptoms,
People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder (ADHD) may be eligible for this study.
Participants are randomly assigned to receive either slow-release methylphenidate (an approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol treatment program, which includes a standardized 12-week behavioral therapy course and treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week with the standard NIAAA treatment evaluation battery, including:
- Timeline Followback: A validated self-report method to assess a person's drinking over a defined interval in time
- Addiction Severity Index: A validated interview that measures problem severity in seven areas related to drug and alcohol abuse
- Biomarkers for alcohol abuse
- Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)
Detailed description
Background: Several pharmacological therapies for relapse prevention in alcoholism have now been documented for efficacy. A key issue that has emerged is the role of patient compliance with medication in mediating efficacy. Psychological traits common among alcoholics interact with treatment compliance. Thus, a considerable proportion of alcoholics, e.g. more than one third of treatment seeking populations, display signs and symptoms of adult ADHD. The impaired ability for long term planning and sustained goal-oriented behaviors in this group is likely to impair compliance with pharmacological treatment, thus reducing its potential beneficial effects.
Well documented pharmacological treatments are also available for ADHD. Among these, methylphenidate has a strong documentation, and has been demonstrated to be as efficacious in adult ADHD as in the childhood condition. A recently introduced slow release preparation of methylphenidate appears to offer considerable advantages, in that it eliminates most of the abuse potential, and allows once daily administration.
Aims: The aim of this study is to evaluate whether addition of methylphenidate to a state of the art treatment program for alcohol dependence will improve clinically relevant treatment outcomes such as validated measures of alcohol drinking.
Methods: The hypothesis will be addressed in a 12 week randomized, placebo controlled double blind add-on trial. Participation will be offered to subjects with alcohol dependence, aged 21-65 years, who enter the NIAAA alcohol treatment program, do not have any severe psychiatric or physical morbidity, and meet criteria for adult ADHD. All patients who are included will be given a standardized state of the art 12 week behavioral treatment package, as well as naltexone, an approved medication for relapse prevention. In addition subjects will be randomized to slow release methylphenidate or corresponding placebo. Patients will be evaluated upon weekly visits using the standard NIAAA treatment evaluation battery TLFB, ASI, biomarkers, as well as the established CAARS rating scale for attention deficit / hyperactivity. Primary outcome will be measures of drinking obtained by the TLFB methodology. Secondary outcomes will measures of attention deficit and hyperactivity, as measured by the CAARS scores.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 or older.
- DSM-IV diagnosis of alcohol dependence or alcohol abuse on SCID, and alcohol problems as primary complaint among SUD:s
- DSM-IV diagnosis of ADHD on SCID, confirmed by CAARS-INV
Key exclusion criteria (25 listed)
- People who present with complicated medical problems requiring intensive medical or diagnostic management, such as hypertensive emergency, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease.
- People who are infected with the Human Immunodeficiency Virus (HIV).
- Serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment, such as psychotic illness or severe dementia (incompetent individuals).
- People who are unlikely or unable to complete the treatment program because they become or are likely to be incarcerated while on the protocol.
- People who are required to receive treatment by a court of law or who are involuntarily committed to 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 |
|---|---|---|
| Methylphenidate | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12878918COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions for alcohol dependence (the COMBINE study): a pilot feasibility study. Alcohol Clin Exp Res. 2003 Jul;27(7):1123-31. doi: 10.1097/01.ALC.0000078020.92938.0B.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Alcoholism and Attention Deficit Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 25 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 2 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261872, 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 2 Jul 2017.