Attention Deficit Disorder With HyperactivityPhase 2AtomNCT00218543

Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 2 study testing Atomoxetine in people with Attention Deficit Disorder With Hyperactivity and Cocaine-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders
What is being tested?: Atomoxetine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jun 2004to Mar 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Meets DSM-IV criteria for cocaine dependence and adult ADHD
Describes cocaine as the primary drug of abuse
Meets DSM-IV criteria for cocaine dependence

Who cannot join

Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
Current major depression
Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia [systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100])
Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
Diabetes
Coronary vascular disease, as indicated by a history or suspected by an abnormal electrocardiogram

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History of cardiac symptoms
History of seizures
Narrow angle glaucoma
Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with atomoxetine
Currently taking prescribed psychotropic medications
Currently taking medications for the treatment of ADHD
Known sensitivity to atomoxetine
Current suicidal ideation or history of suicidal or homicidal behavior within 2 years prior to study entry
Pregnant or breastfeeding
Physiologically dependent on any drugs other than nicotine or marijuana
History of schizophrenia, bipolar disorder, or other psychotic disorders
Currently taking cough medicine (e.g., dextromethorphan) and/or albuterol

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Foundation for Mental Hygiene, Inc.
New York, New York, 10032

Other trials in United States

About this study

Official title: Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial

Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

Read the detailed description

ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder. This may be reflective of an attempt by individuals with ADHD to self-treat symptoms. Atomoxetine is an FDA-approved drug that is used to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. The drug is in a class of medications called selective norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine, a natural substance in the brain that affects a person's attention and impulsivity. It is possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their need for cocaine. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

Participants in this open label study will receive atomoxetine for 12 weeks, and will take one dose each morning for the duration of the study. Doses will be increased gradually to minimize side effects and enhance treatment compliance. In addition, all participants will receive individualized relapse prevention therapy once weekly. Participants will be required to report to the study site three times a week to receive medication, complete questionnaires regarding ADHD symptoms and substance use behavior, and provide a urine sample while being supervised by study staff. Also, vital signs will be monitored and medication side effects will be assessed at each visit. Participants will report to the study site 6 months after starting in the study for a follow-up visit, at which time ADHD symptoms, substance use behavior, and social functioning will be assessed.

Conditions: Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders
Being tested: Atomoxetine
Keywords: ADHD, Cocaine Abuse
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtomoxetineDrug
At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.

Study groups in NCT00218543
Study group	Role	What they receive
Atomoxetine	Experimental	Atomoxetine Receives: Drug: Atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

the Adult ADHD Rating Scale (AARS) (30% Reduction)
AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.
Measured: baseline compared to rating at week 12 or last rating during study participation
ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.
Measured: measured during 12 weeks or length of study participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004Mar 2007

First posted22 Sep 2005 (estimated)
Study startJun 2004
Primary completionMar 2007
Study completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Disorder With HyperactivityStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00218543
Sponsor's protocol ID: #4611
Other IDs: P50DA009236, P50-09236-12, DPMC
Acronym: Atom
Status last verified: Apr 2019
First submitted: 20 Sep 2005
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial
ClinicalTrials.gov ID: NCT00218543
Acronym / sponsor ID: Atom / #4611
Conditions: Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders
Keywords: ADHD, Cocaine Abuse
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jun 2004
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 4 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Atomoxetine	Experimental	Drug: AtomoxetineAtomoxetine

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Meets DSM-IV criteria for cocaine dependence and adult ADHD
Describes cocaine as the primary drug of abuse
Meets DSM-IV criteria for cocaine dependence

Key exclusion criteria (18 listed)

Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
Current major depression
Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia [systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100])
Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
Diabetes

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
AtomoxetineAt the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.	Drug	Atomoxetine

Primary outcome

the Adult ADHD Rating Scale (AARS) (30% Reduction)
Time frame: baseline compared to rating at week 12 or last rating during study participation
AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.
ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
Time frame: measured during 12 weeks or length of study participation
Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.

Results and safety

Results posted to the registry on 4 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atomoxetine	20	5

Primary outcome: the Adult ADHD Rating Scale (AARS) (30% Reduction)

Time frame: baseline compared to rating at week 12 or last rating during study participation. Number. Unit: percent of participants

Measure	Atomoxetine n = 20
Value	50

Population analysed: All participants

Primary outcome: ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)

Time frame: measured during 12 weeks or length of study participation. Mean (Standard Deviation). Unit: scores on a scale

Measure	Atomoxetine n = 18
baseline	31.4 (9.8)
end of study	21.2 (12.4)

Population analysed: Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed

Adverse events

Time frame: 12 weeks or length of study participation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atomoxetine	0 of 20 (0%)	5 of 20 (25%)	Not reported

Limitations and caveats (from the sponsor): Clearly, there are limitations of this study including the high drop-out rate, small sample size, and lack of a control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for the Substance Treatment and Research Service websiteLink provided by the sponsor.

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

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.

Herbert Kleber, MD principal investigator

New York State Psychiatric Institute

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 Atomoxetine in people with Attention Deficit Disorder With Hyperactivity and Cocaine-Related Disorders, run by New York State Psychiatric Institute 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 18 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 24 Apr 2019. 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?

Yes. Results are posted in the registry (first posted 4 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Adult ADHD Rating Scale (AARS) (30% Reduction) (time frame: baseline compared to rating at week 12 or last rating during study participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00218543.

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 24 Apr 2019.