Methamphetamine has become a major public health issue in both the US and globally. Despite this, no effective pharmacotherapy for methamphetamine abuse has been developed to date. This 6 week, open-label pilot clinical trial examined the safety and tolerability of modafinil up to 400mg/day in eight methamphetamine dependent individuals. Subjects were inducted onto modafinil at 400 mg/day over three days and remained on 400 mg/day for 4.5 weeks. Participants received weekly blister packs and underwent weekly individual cognitive behavioral therapy. Adjunctive contingency management procedures were used to enhance retention. Vital signs and supervised urine samples were obtained thrice weekly and self-reported drug use and Hamilton Anxiety and Depression ratings were completed once weekly. Eight subjects (50% female, 100% Caucasian, aged 35-52 yrs) were enrolled. Four completed the 6-wk study, 3 completed a portion and one withdrew consent before completing intake. Results showed that systolic blood pressure (t=1.09, p=0.28), diastolic blood pressure, (t=1.18, p=0.24) and heart rate (t=1.55, p=0.13) did not change over time. Scores on the modafinil side effects checklist (t=−2.63, p=0.01), Hamilton Anxiety scale (t=−2.50, p=0.018) and Hamilton Depression scale (t=−3.25, p=0.003) all decreased over time. The proportion of urine positive for amphetamines did not change over time (t=−0.52, p=0.61), whereas self-reported methamphetamine use did (t=−2.86, p<0.005). These results suggest that modafinil at 400 mg/day is safe and tolerable for methamphetamine dependent individuals.
Background Cocaine dependence is a major public health problem with no available robustly effective pharmacotherapy. This study’s aim was to determine if treatment with sertraline (SERT) or SERT plus gabapentin (GBP) improved treatment retention, depressive symptoms, and/or cocaine use. Methods Depressed cocaine-dependent patients (N = 99) were enrolled in a 12-week, double-blind, randomized, placebo (PLA)-controlled, clinical trial and placed in research beds at a residential treatment facility (Recovery Centers of Arkansas). They were randomized by depressive symptom severity and inducted onto 1 of the following while residing at the Recovery Centers of Arkansas: SERT (200 mg/d), SERT (200 mg/d) plus GBP (1200 mg/d), or PLA. Participants transferred to outpatient treatment at the start of their third week, continued receiving study medications or PLA (weeks 3–12), and participated in weekly individual cognitive behavioral therapy. Compliance was facilitated through the use of contingency management procedures. Supervised urine samples were obtained thrice weekly and self-reported mood weekly. At the end of 12 weeks, participants were tapered off the study medication over 5 days and referred to a local treatment program. Results Sertraline, but not SERT plus GBP, showed a significantly lower overall percentage of cocaine-positive urine samples compared with that of PLA. A significantly greater percentage of participants experienced relapse in the PLA group (88.9%) compared with that of the SERT group (65.2%). Hamilton depression ratings decreased significantly over time regardless of the treatment group. Retention in treatment did not differ significantly between the treatment groups. Conclusions Sertraline plus GBP may not be superior to SERT alone in delaying relapse among abstinent cocaine-dependent individuals undergoing cognitive behavioral therapy.
Background: Given the immense burden of the widespread use of opioids around the world, exploring treatments that improve drug use outcomes, and craving and withdrawal measures in individuals with opioid use disorder is crucial. This pilot study examined the feasibility and preliminary efficacy of the L-type calcium-channel blocker isradipine (ISR) to improve drug use outcomes, and craving and withdrawal measures during buprenorphine (BUP)/ISR stabilization and subsequent taper in opioid-dependent individuals. Methods: Participants were stabilized on BUP sublingual tablets within the first 2 days of week 1, were then randomized and inducted on either ISR or placebo, gradually increasing the dose over the next 2 weeks, followed by a 10-day BUP taper during weeks 5-6, and ISR/placebo taper during weeks 7 to 8. Assessments included thrice-weekly measures of craving and withdrawal, as well as vital signs and urine drug screens. Medication compliance was assessed by monitoring number of missed clinic visit days. Results: Baseline characteristics of participants (n = 25; 60% male, 96% Caucasian, 48% employed, mean age 32.8 years) did not differ significantly between treatment groups (isradipine, n = 11; placebo, n = 14). During the stabilization phase (n = 19), ISR participants had significantly lower rates of illicit opioid-positive urines (treatment × visit: t = -2.16, P = 0.03), as well as reduction in craving intensity ( t = –2.50, P = 0.01), frequency ( t = –3.43, P < 0.01) and duration ( t = –2.51, P = 0.01). ISR was well tolerated with mild adverse effects. Conclusions: This study was likely underpowered due to being a pilot trial. Although preliminary results suggest ISR may improve BUP-assisted treatment outcomes, concerns about high number of exclusions (n = 11 during taper phase) based on cardiovascular measures as well as ISR-induced changes in vital signs with the immediate release formulation may limit the feasibility of this approach. Trial Registration: Clinicaltrials.gov identifier NCT01895270. Registered 10 July 2013, https://clinicaltrials.gov/ct2/show/NCT01895270?id=NCT01895270&draw=2&rank=1
This randomized clinical trial retrospectively examined the effect of Post Traumatic Stress Disorder (PTSD) and contingency management (CM) on cocaine use in opioid and cocaine dependent individuals maintained on high or low-dose LAAM randomly assigned to CM or a yoked-control condition. Cocaine-positive urines decreased more rapidly over time in those without PTSD versus those with PTSD in the non-contingency condition. In participants with PTSD, CM resulted in fewer cocaine positive urines compared to the non-contingent condition. This suggests that CM may help improve the potentially worse outcomes in opioid-and cocaine dependent individuals with PTSD compared to those without PTSD.
This report was produced in response to a request by the Senate Committee on Appropriations that the National Advisory Mental Health Council prepare and submit a report on the cost of insurance coverage of medical treatment for severe mental illness commensurate with the coverage of other illnesses and an assessment of the efficacy of treatment of severe mental disorders. About 5 million Americans (2.8% of the adult population) experience severe mental disorders in a 1-year period. Treating these disorders now costs the nation an estimated $20 billion a year (with an additional $7 billion a year in nursing home costs). These costs represent 4% of total U.S. direct health care costs. When the social costs are also included, severe mental disorders exact an annual financial toll of $74 billion. This total accounts for the dollar costs of shortened lives and lost productivity, as well as the costs incurred in the criminal justice and social service systems. However, it cannot begin to account in human terms for the enormous emotional cost and pain borne by Americans with severe mental illness and by their families. Many myths and misunderstandings contribute to the stigmatization of persons with mental illness and to their often limited access to needed services. For example, millions of Americans and many policy makers are unaware that the efficacy of an extensive array of treatments for specific mental disorders has been systematically tested in controlled clinical trials; these studies demonstrate that mental disorders can now be diagnosed and treated as precisely and effectively as are other disorders in medicine. The existence of effective treatments is only relevant to those who can obtain them. Far too many Americans with severe mental illness and their families find that appropriate treatment is inaccessible because they lack any insurance coverage or the coverage they have for mental illness is inequitable and inadequate. For example, private health insurance coverage for mental disorders is often limited to 30-60 inpatient days per year, compared with 120 days or unlimited days for physical illnesses. Similarly, the Medicare program requires 50% copayment for outpatient care of mental disorders, compared with 20% copayment for other medical outpatient treatment. These inequities in both the public and private sectors can and should be overcome.(ABSTRACT TRUNCATED AT 400 WORDS)
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