Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | February 2014 |
| Contact: | Jerry A Rushing |
| Email: | JARushing@uams.edu |
| Phone: | 501-526-7969 |
Methamphetamine dependence is a serious public health problem, with methamphetamine abusers
being at risk for significant morbidity and mortality, including HIV. To date, no medication
or psychotherapeutic strategy has shown robust, long-term efficacy in treating this
disorder. This clinical trial will examine whether lisdexamfetamine shows promise in
alleviating withdrawal symptoms and preventing relapse relative to placebo in
recently-abstinent methamphetamine dependent individuals. Findings of this study will not
only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but
also inform future medication development strategies for improving treatment for drug
dependence disorders. Discovering efficacious limited risk interventions that show more
robust, longer-term outcomes would be beneficial both to the individual and society.
being at risk for significant morbidity and mortality, including HIV. To date, no medication
or psychotherapeutic strategy has shown robust, long-term efficacy in treating this
disorder. This clinical trial will examine whether lisdexamfetamine shows promise in
alleviating withdrawal symptoms and preventing relapse relative to placebo in
recently-abstinent methamphetamine dependent individuals. Findings of this study will not
only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but
also inform future medication development strategies for improving treatment for drug
dependence disorders. Discovering efficacious limited risk interventions that show more
robust, longer-term outcomes would be beneficial both to the individual and society.
Inclusion Criteria:
1. Age (18-65 yrs).
2. Participants must fulfill DSM-IV criteria for Methamphetamine dependence These
criteria will be ascertained in the following manner: the physician will determine
whether the individual is appropriate based on clinical assessments and the patient
will also need to meet criteria for methamphetamine dependence based on
administration of the SCID.
3. Self-reported average METH use of at least 250 mg of methamphetamine per occasion at
least once weekly during the preceding 3-month period.
4. A positive urine toxicology screen for methamphetamine. Participants must submit a
urine sample negative for drugs of abuse (opiates, benzodiazepines, cocaine and PCP)
other than methamphetamine or marijuana during the week prior to starting the study.
5. Women of child-bearing potential will be included provided they 1) have a negative
pregnancy test, 2) agree to adequate contraception (tubal ligation, hysterectomy,
barrier contraceptive method or oral contraceptive method) to prevent pregnancy
during the study and 3) are not nursing.
6. Normal blood pressure with SBP >89 and < 141, DBP >59 and < 91.
Exclusion Criteria:
1. Current suicidality or psychosis
2. Current cocaine dependence or opioid, alcohol, or sedative physical dependence
3. Major hepatic or cardiovascular disorder (including history of myocardial infarction,
cardiovascular disease, or history of or currently clinically significant ECG
abnormality) or unstable medical condition that contraindicates study participation
4. History of schizophrenia or bipolar type I disorder
5. Use of medications that would be expected to have major interaction with LDX
including psychotropics
6. Medical contraindication to receiving LDX
7. Positive drug screen for cocaine, opiates, sedatives or PCP.
8. History of Seizure disorder
9. Documented hypersensitivity to sympathomimetic amines
10. LFT >3xULN
11. Pregnancy/nursing
12. Current use or past 2 weeks use of MAOi
13. History of Narrow-angle glaucoma
g.n. History of Hyperthyroidism
We found this trial at
1
site
Litle Rock, Arkansas 72205
Principal Investigator: Michael J Mancino, MD
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