DESOXYN SUMMARY
PHARMACIST: Med Guide PROVIDED SEPARATELY AND IS TO BE INCLUDED
WITH PRESCRIPTION FOR EACH PATIENT.
Also available at www.ovationpharma.com.
C-II
DESOXYN (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N, (alpha)-dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines.
Attention Deficit Disorder with Hyperactivity
—DESOXYN tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Exogenous Obesit
—as a short-term (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of DESOXYN tablets (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below.
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NEWS HIGHLIGHTSMedia Articles Related to Desoxyn (Methamphetamine)
$17 Million To UC San Diego For Methamphetamine/AIDS Research
Source: HIV / AIDS News From Medical News Today [2009.11.15]
Igor Grant, MD, professor of psychiatry at the University of California, San Diego School of Medicine, and colleagues have been awarded a $17 million grant from the National Institute on Drug Abuse to establish the Translational Methamphetamine AIDS Research Center (TMARC) at UC San Diego. Grant is director of the HIV Neurobehavioral Research Center (HNRC), a clinical research center designated and funded by the National Institute of Mental Health.
Published Studies Related to Desoxyn (Methamphetamine)
Predicting adherence to treatment for methamphetamine dependence from neuropsychological and drug use variables. [2009.11.01]
Although some individuals who abuse methamphetamine have considerable cognitive deficits, no prior studies have examined whether neurocognitive functioning is associated with outcome of treatment for methamphetamine dependence. In an outpatient clinical trial of bupropion combined with cognitive behavioral therapy and contingency management (Shoptaw, S., Heinzerling, K.G., Rotheram-Fuller, E., Steward, T., Wang, J., Swanson, A.N., De La Garza, R., Newton, T., Ling, W., 2008...
Correlates of incarceration among young methamphetamine users in Chiang Mai, Thailand. [2009.07]
OBJECTIVES: We examined correlates of incarceration among young methamphetamine users in Chiang Mai, Thailand in 2005 to 2006... CONCLUSIONS: Incarcerated methamphetamine users are engaging in behaviors and being exposed to environments that put them at increased risk of infection and harmful practices. Alternatives to incarceration need to be explored for youths.
Effects of oral methamphetamine on cocaine use: a randomized, double-blind, placebo-controlled trial. [2009.04.01]
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.
Depression among methamphetamine users: association with outcomes from the Methamphetamine Treatment Project at 3-year follow-up. [2009.04]
Although depression is highly comorbid with substance use disorders, little is known about the clinical course and outcomes of methamphetamine (MA) users with depressive symptoms and syndromes. In this study of MA-dependent individuals entering psychosocial treatment, we predicted that (1) depressive symptoms would decline during treatment, an effect that would vary as a function of MA use and (2) depression diagnoses post-treatment would be associated with poorer outcomes...
Risk factors associated with methamphetamine use and heart failure among native Hawaiians and other Pacific Island peoples. [2009]
OBJECTIVE: Heart failure (HF), a long term outcome of chronic methamphetamine use (MU), occurs more frequently in racial and ethnic minority populations at high risk for cardiovascular disparities. This study examined the association of socio-demographic and clinical risk factors with MU among heart failure patients who are Native Hawaiians (NH) or other Pacific Island peoples (PIP)... CONCLUSIONS: RISK FACTORS ASSOCIATED WITH MU IN NH AND PIPS WITH HEART FAILURE INCLUDE: younger age and being divorced/separated or never married. Health care providers should be aware of MU as a contributing factor in the approach and treatment of HF in NHs and PIPs.
Clinical Trials Related to Desoxyn (Methamphetamine)
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study [Recruiting]
Methamphetamine use has escalated in recent years. Methamphetamine use has also spread
throughout the country. Although much information has been gathered on the treatment of
cocaine abuse, very little information has been obtained on the treatment of methamphetamine
abuse. One of the first steps in developing appropriate treatment is to examine the effects
of stopping a particular substance's use on individuals abusing that substance. To date this
has not been well studied for people abusing methamphetamine. The purpose of this study is to
better understand and develop accurate ways of measuring symptoms associated with stopping
the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal
symptoms are able to be effectively measured, this will help to develop treatments targeted
at alleviating these symptoms. These symptoms are often associated with relapse to use of
that substance.
Topiramate for the Treatment of Methamphetamine Dependence - 1 [Completed]
The purpose of this study is to assess the efficacy and safety of topiramate as compared to
placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
Cardiovascular Response and Adverse Events Associated With Perindopril in Treating Methamphetamine Dependent Individuals - 1 [Recruiting]
Due to its ease of synthesis and powerful psychostimulant effects, abuse of methamphetamine
has increased rapidly over the last decade. No medications are currently approved for the
treatment of methamphetamine dependence or withdrawal. The purpose of this study is to
determine whether perindopril, an angiotensin converting enzyme (ACE) inhibitor, modifies
cardiovascular responses and adverse events when taking methamphetamines.
Modafinil for Methamphetamine Dependence [Not yet recruiting]
STUDY OBJECTIVES: To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
STUDY DESIGN: This is a double-blind, placebo-controlled, parallel-group study in which, after a 14-day screening/baseline period, subjects will be randomly assigned to one of three treatment arms. Subjects will receive 200 mg modafinil, 400 mg modafinil or matched placebo daily for 12 weeks, with a follow-up assessment 4 weeks after treatment completion/termination. Adaptive randomization will be used to balance treatment groups based on site, gender, ADHD, and frequency of historical self report of methamphetamine use in the 30 days prior to informed consent (18 versus >18).
STUDY POPULATION: Two hundred and ten subjects with Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for methamphetamine dependence, determined by structured clinical interview (SCID), will be randomized into one of three treatment arms (70 subjects per arm). The subject population will include those who provide at least one methamphetamine-positive urine during the 2-week screening/baseline period prior to randomization, and who verbalize the ability to understand and provide written informed consent.
TREATMENTS: During the 12 weeks of treatment, subjects will receive 200 mg or 400 mg of modafinil daily, or matched placebo. Modafinil/placebo is administered orally once a day. All subjects will receive standardized psychosocial therapy, which will consist of manual-guided cognitive behavioral therapy (CBT) three times a week during the 12-week study drug administration period. Human immunodeficiency virus (HIV) counseling will be provided at baseline, at the end of study participation, and at follow-up.
SAFETY ASSESSMENTS: All potential subjects for study enrollment will have a physical examination, a 12-lead electrocardiogram (ECG), clinical laboratory studies (blood chemistry, hematology, infectious diseases, urinalysis, and pregnancy test, if female), and the Hamilton Depression Rating Scale (HAM-D) completed during screening/baseline. Vital signs, concomitant medication use, and a urine screen for other substances of abuse will be assessed three times per week during screening/baseline and weekly during the study drug administration period. A HAM-D and clinical laboratory studies (including a pregnancy test, if female) will be performed at weeks 4, 8, and 12. Adverse Events (AEs) will be assessed three times per week during the screening/baseline period and at each study visit, and reviewed by a study physician once a week. At week 12 or at the time of study discontinuation, all subjects will have an ECG, vital signs, physical examination, HAM-D, clinical laboratory studies (including pregnancy test, if female) and an AE assessment. A final AE assessment will be performed at the follow-up 4 weeks after study completion/termination.
EFFICACY ASSESSMENTS: The primary efficacy outcome measure is methamphetamine use or non-use weeks during the study medication administration period. Secondary assessments include analyses of other measures of success in the reduction of methamphetamine use including the proportion of successful subjects with 21 consecutive days of abstinence in which all urine samples are negative for methamphetamine, the maximum number of consecutive methamphetamine non-use days, reductions in methamphetamine use as compared to baseline, treatment effects on other substances of abuse and reduction in scores of HIV risk-taking behavior assessed by the HIV Risk-Taking Behavior Scale (HRBS). Severity of methamphetamine dependence will be assessed by comparing the change in scores of the Addiction Severity Index (ASI-Lite and ASI-Lite Follow-up), Brief Substance Craving Scale (BSCS), and Clinical Global Impression as assessed by the subject (CGI-S) and an observer (CGI-O). The ASI-Lite will be performed at screening/baseline and the ASI-Lite Follow-up at the first visit of weeks 4 and 8, and at week 12 or early termination. The BSCS, CGI-S, and CGI-O will be performed at each week during screening/baseline and at the first visit of each study week during the study medication administration period. The HRBS will be used to characterize the population. s HIV risk-taking behavior at baseline, at the end of the study, and at follow-up. End-of-study assessments to be performed if a subject completes the protocol or is terminated early for any reason are listed in Section 13.
Topiramate for Methamphetamine Dependence [Recruiting]
This study seeks to evaluate the safety and the efficacy of the drug, topiramate, for the treatment of metamphetamine dependence.
This is a double-blind, placebo-controlled, randomized clinical trial. One hundred forty (140) males and females seeking treatment for methamphetamine dependence will be randomly assigned (based on site & methamphetamine use status) to one of two treatment conditions. Half of all participants will receive topiramate and half will receive a matched placebo for 91 days.
Analyses will be done after treatment to evaluate the efficacy of topiramate versus placebo for the treatment of methamphetamine dependence. The primary outcome measure is the weekly proportion of methamphetamine-free urine samples throughout treatment. Other measures of success will include: 1) the proportion of participants with 21 consecutive days of abstinence; 2) the proportion of self-reported methamphetamine non-use days; 3) the largest number of consecutive methamphetamine non-use days; and 4) reductions in use as compared to baseline.
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Page last updated: 2009-11-15
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