Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Pulmonary |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/30/2018 |
| Start Date: | December 2007 |
| End Date: | July 2013 |
A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence
The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the
safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine
dependence. Since this medication has independently shown promise in helping with ADHD and
cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD
and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives
of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and
improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine
dependence. Since this medication has independently shown promise in helping with ADHD and
cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD
and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives
of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and
improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
Specific Aim 1: To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD
improvement among comorbid ADHD and cocaine-dependent patients.
Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to
least reductions from 80mg>60mg>PBO (placebo).
Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from
80mg>60mg>PBO.
Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and
impulsivity among comorbid ADHD and cocaine-dependent patients.
Hypothesis 4: There will be greater improved CGI (clinical global impression scale) scores in
participants receiving d-AMPH (d-amphetamine) compared to PBO.
Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts
Impulsivity Scale) and behavioral measures (Card Sort, IMT (immediate memory task), DMT
(delayed memory task), BART) compared to PBO.
This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups,
randomized PBO-controlled trial with a lead-in as well as medication run-up and run down
weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which
if successful will lead to improved treatment for A-ADHD/S-SUD.
improvement among comorbid ADHD and cocaine-dependent patients.
Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to
least reductions from 80mg>60mg>PBO (placebo).
Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from
80mg>60mg>PBO.
Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and
impulsivity among comorbid ADHD and cocaine-dependent patients.
Hypothesis 4: There will be greater improved CGI (clinical global impression scale) scores in
participants receiving d-AMPH (d-amphetamine) compared to PBO.
Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts
Impulsivity Scale) and behavioral measures (Card Sort, IMT (immediate memory task), DMT
(delayed memory task), BART) compared to PBO.
This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups,
randomized PBO-controlled trial with a lead-in as well as medication run-up and run down
weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which
if successful will lead to improved treatment for A-ADHD/S-SUD.
Inclusion Criteria:
1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine
dependence and adult ADHD (DSM-IV-TR).
2. Used cocaine at least four days in the past month
3. Must have a Body Mass Index (BMI) > 18 kg/m2
4. Alcohol Breathalyzer (BraC) at consent of < 0.04%
5. Individuals must be capable of giving informed consent and capable of complying with
study procedures.
6. Women of child bearing age will be included in the study provided that they are not
pregnant, based on the results of a blood pregnancy test drawn at the time of
screening. They must also agree to use a method of contraception with proven efficacy
and agree not to become pregnant during the study. To confirm this, blood pregnancy
tests will be repeated monthly. Women will be provided a full explanation of the
potential dangers of pregnancy while on the study medication. If a woman becomes
pregnant, the study medication will be discontinued.
Exclusion Criteria:
1. Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder
other than transient psychosis due to drug abuse.
2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR
supported by the SCID-I/P that in the investigator's judgment are unstable or would be
disrupted by study medication or are likely to require pharmacotherapy during the
study period.
3. Individuals with current major depressive disorder.However,individuals who are
currently stable on a psychotropic medication for three months with a HAM-D <14 may be
included.
4. Individuals physiologically dependent on any other drugs (excluding nicotine or
cannabis) which require medical intervention.
5. Individuals with current suicidal risk.
6. Individuals with coronary vascular disease as indicated by history or suspected by
abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and
family history of ventricular tachycardia/sudden death.
7. Unstable physical disorders which might make participation hazardous such as
uncontrolled hypertension (SBP > 140, DBP> 90, or HR > 100 when sitting quietly),
acute hepatitis (patients with chronic mildly elevated transaminases < 3x upper limit
of normal are acceptable), or uncontrolled diabetes.
8. Individuals with a history of seizures
9. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS).
10. Women who are pregnant or nursing.
11. History of failure to respond to a previous adequate trial of the candidate medication
for cocaine dependence
12. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other
penalties, etc.) to participate in substance abuse treatment program
13. History of glaucoma
14. Individuals who report use of MAOI within 14 days of study start
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