AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
ADDERALL XR SUMMARY
ADDERALL XR® CAPSULES CII Rx Only
ADDERALL XR® is a once daily extended-release, single-entity amphetamine product. ADDERALL XR® combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine sac-charate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR® capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR® compared to the conventional ADDERALL® (immediate-release) tablet formulation.
ADDERALL XR® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of ADDERALL XR® in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, and one controlled trial in adults who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY), along with extrapolation from the known efficacy of ADDERALL®, the immediate-release formulation of this substance.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet
activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program: ADDERALL XR® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
Long-Term Use: The effectiveness of ADDERALL XR® for long-term use, i.e., for more than 3 weeks in children and 4 weeks in adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL XR® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Published Studies Related to Adderall XR (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
Effects of oral methamphetamine on cocaine use: A randomized, double-blind, placebo-controlled trial. [2008.12.04]
BACKGROUND: No medication is currently approved for the treatment of cocaine dependence, but several preclinical and clinical reports suggest agonist-like medications, e.g., amphetamine analogues, may be a productive strategy for medication development. OBJECTIVE: This current proof-of-concept study sought to evaluate the safety, tolerability, and effectiveness of methamphetamine as a candidate treatment for cocaine dependence... CONCLUSIONS: SR methamphetamine significantly reduced cocaine use and craving. Additional research is warranted to develop and evaluate agonist-like medications that may effectively treat cocaine dependence.
Evaluation of subjective effects of aripiprazole and methamphetamine in methamphetamine-dependent volunteers. [2008.12]
A variety of neuropharmacological strategies are being pursued in the search for an effective treatment for methamphetamine (Meth) addiction. In this study, we investigated the safety and potential efficacy of aripiprazole, an antipsychotic agent acting on both dopamine and serotonin systems... Further research with lower doses of aripiprazole, possibly using study designs aimed at evaluating efficacy for relapse prevention, are needed before ruling out aripiprazole as a treatment for Meth dependence.
Attention-deficit/hyperactivity disorder-specific quality of life with triple-bead mixed amphetamine salts (SPD465) in adults: Results of a randomized, double-blind, placebo-controlled study. [2008.11.04]
CONCLUSIONS: Adults with ADHD showed significantly improved QOL for both ADHD-specific and global measures with triple-bead MAS in comparison to placebo, based on AIM-A scores. Treatment-emergent adverse events were mostly mild to moderate in intensity and were consistent with amphetamine treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00150579. (c) Copyright 2008 Physicians Postgraduate Press, Inc.
Naltrexone for the treatment of amphetamine dependence: a randomized, placebo-controlled trial. [2008.11]
CONCLUSIONS: This trial demonstrated the efficacy of naltrexone in reducing amphetamine use in amphetamine-dependent individuals.
Restoration of risk-propensity during sleep deprivation: caffeine, dextroamphetamine, and modafinil. [2008.09]
INTRODUCTION: Sleep deprivation alters risk-related judgments, decision-making, and behavioral control. Stimulant medications are used to restore cognitive performance, but their effects on risk-taking and judgment in sleep-deprived subjects have not been explored... CONCLUSIONS: Stimulant medications, particularly dextroamphetamine, sustained risk-related attitudes and behavior during continuous wakefulness. The extent to which stimulants restore other aspects of judgment during sleep loss remains to be determined.
Clinical Trials Related to Adderall XR (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence [Recruiting]
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.
Adderall XR and Processing Speed in Multiple Sclerosis (MS) [Not yet recruiting]
Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis
(MS) and can occur independently of physical disability. It is the most common reason, along
with physical fatigue, for MS patients to stop working. The most frequent complaint is
problems with multi-tasking or thinking quickly, which corresponds to impairment in the
cognitive domain of processing speed. Currently there is treatment available to prevent
relapses and physical disability but there are no medications that have been shown to treat
cognitive impairment. Amphetamines have been beneficial for selective attention and
processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain
injury. This is study will determine whether Adderall XR improves objective measures of
processing speed and attention in MS patients impaired in this cognitive domain, by
comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication
is administered. The results of this study will help provide data to design a larger study
to determine if Adderall XR, and potentially other amphetamine drugs, will help treat
cognitive impairment in MS patients.
Free Treatment for Cocaine Dependence: A Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence [Recruiting]
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety
and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.
Since both of these medications have independently shown promise in helping with cocaine
abuse we are proposing that together they may be even more successful in the treatment of
cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of
the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine
abstinence among cocaine-dependent patients. This study includes free treatment for cocaine
dependence that includes medication.
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD [Completed]
The purpose of this study is to assess, in a controlled environment, the efficacy and safety
of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD [Completed]
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 12 ratings/reviews, Adderall XR has an overall score of 7.17. The effectiveness score is 9 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Adderall XR review by 54 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || Adult ADD|
|Dosage & duration:|| || 20 mg. taken 1 x day for the period of 2004 to present|
|Other conditions:|| || asthma, allergies|
|Other drugs taken:|| || flovent, flonase, albuteral inhaler|
|Benefits:|| || In a very short period of time, there was a mental clarity that I had never experienced. I felt a calm and order to my life and work. I was truly able to focus on important things that I needed to do and did so efficiently, which was something I was never able to do. Menopause exacerbated the extreme mental fuzziness that I had already been experiencing with 4 children and a more than full time job. This drug has truly changed my life for the better!|
|Side effects:|| || I did not experience any side effects that were negative. I could hear better and think in a focused way within a short amount of time (30-45 minutes after taking the drug) |
|Comments:|| || I take a 30 mg. pill shortly after waking and within an hour, the fog that I chronically have had all of my life just lifts!|
Adderall XR review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || ADD|
|Dosage & duration:|| || 30 mg taken once a day for the period of ongoing|
|Other conditions:|| || mood swings|
|Other drugs taken:|| || lexapro|
|Benefits:|| || Being more focused....alert...helped with over eating|
|Side effects:|| || when not taken I felt tired, and ate alot |
|Comments:|| || I took it once a day.. in the beginning it worked great but over time it didnt seem to be to effective... i took it for about 7 yrs. One thing is now that i am not taking it i eat more. i stopped taking lexapro 2yrs before. This didnt seem to help |
Adderall XR review by 17 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || ADHD|
|Dosage & duration:|| || 70mg taken once daily for the period of 3 years|
|Other conditions:|| || none|
|Other drugs taken:|| || effexor|
|Benefits:|| || i cant list very many benefits because my expierience was so bad that i would rather have been dead than have been forced to have taken this pill every day for 3 to 4 years|
|Side effects:|| || i was severly depressed and had a lot of suicide attempts and i thought everyone hated me. i always wanted to be dead and nobody listened to me, they just upped the dosage and with the higher dosage the worse it got|
|Comments:|| || it sucked. sure i didnt have ADHD but i also felt as though i lost my soul in the proccess. i became so depressed i actually began to feel like a shell|
Page last updated: 2009-02-08