Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders
Conditions
Keywords
ADHD, Cocaine Abuse
Brief summary
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.
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.
Interventions
DRUGAtomoxetine
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.
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Adult ADHD Rating Scale (AARS) (30% Reduction) | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were seeking treatment for problems related to cocaine use and were recruited by local advertising/referrals in the New York City area. Two types of adS were placed: (1) ads for treatment of cocaine dependence, and (2) ads for treatment for cocaine dependence and possible problems with inattention and/or hyperactivity.
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Physician Decision | 3 |
| Overall Study | relocated | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Atomoxetine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 39.3 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: measured during 12 weeks or length of study participation
Population: Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) | baseline | 31.4 scores on a scale | Standard Deviation 9.8 |
| Atomoxetine | ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) | end of study | 21.2 scores on a scale | Standard Deviation 12.4 |
Primary
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.
Time frame: baseline compared to rating at week 12 or last rating during study participation
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atomoxetine | the Adult ADHD Rating Scale (AARS) (30% Reduction) | 50 percent of participants |