A 2011 Veterans Health Administration directive mandated medically necessary care for transgender veterans. Internal education efforts informed staff of the directive and promoted greater access to care. For fiscal years 2006 through 2013, we identified 2662 unique individuals with International Classification of Diseases, Ninth Revision diagnoses related to transgender status in Veterans Health Administration medical records, with 40% of new cases in the 2 years following the directive. A bottom-up push for services by veterans and top-down education likely worked synergistically to speed implementation of the new policy and increase access to care.
Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels, obscuring possible medication efficacy. Testing the feasibility of using a prerandomization, abstinence-induction protocol, we screened three candidate medications to explore treatment response in patients who did, or did not, achieve abstinence during an extended baseline phase.
This study examined the feasibility of a prize-based contingency-management (CM) approach to encourage interactive voice response (IVR) compliance in a cocaine-treatment study and explored the association between IVR call rate and outcome during a cocaine abstinence-induction trial. Subjects called into the IVR system daily to complete a brief interview assessing cocaine use for the past 24hours. One group earned $1 for each call; the other earned one draw per call from a "prize bowl" with a range of awards. Abstinence was rewarded according to a high-value voucher incentive schedule, which was the same for both groups, and confirmed by thrice-weekly urine testing at clinic visits. Odds of calling were 4.7 times greater (95% CI: 1.23, 17.91) in the prize-CM group than in the fixed dollar CM group. In addition, the percentage of IVR calls was significantly associated with abstinence achievement, ?(2) (1)=5.147, p<.023. The use of prize-based CM to increase the use of IVR is feasible and deserves examination as an innovation for helping participants engage in treatment.
New data support use of levodopa pharmacotherapy with behavioral contingency management (CM) as one efficacious combination in cocaine dependence disorder treatment. A potential mechanism of the combined treatment effects may be related to dopamine-induced enhancement of the saliency of contingently delivered reinforcers. Evidence to support this mechanism was sought by evaluating levodopa-enhancing effects across distinct CM conditions that varied in behavioral targets. A total of 136 treatment-seeking, cocaine dependent subjects participated in this 12-week, randomized, placebo-controlled trial of levodopa (vs. placebo) administered in combination with one of three behavioral CM conditions. In the CM-URINE condition, subjects received cash-valued vouchers contingent on cocaine-negative urine toxicology results. In the CM-ATTEND condition, the same voucher schedule was contingent on attending thrice weekly clinic visits. In the CM-MEDICATION condition, the same voucher schedule was contingent on Medication Event Monitoring Systems- and riboflavin-based evidence of pill-taking behavior. Primary outcomes associated with each CM target behavior were analyzed using generalized linear mixed models for repeated outcomes. CM responding in the CM-ATTEND and CM-MEDICATION conditions showed orderly effects, with each condition producing corresponding changes in targeted behaviors, regardless of medication condition. In contrast, CM responding in the CM-URINE condition was moderated by medication, with levodopa-treated subjects more likely to submit cocaine-negative urines. These findings specify the optimal target behavior for CM when used in combination with levodopa pharmacotherapy.
This randomized, double-blind, placebo-controlled study compared the effects of high-dose (100 mg/d) naltrexone versus placebo in a sample of 87 randomized subjects with both cocaine and alcohol dependence. Medication conditions were crossed with two behavioral therapy platforms that examined whether adding contingency management (CM) that targeted cocaine abstinence would enhance naltrexone effects compared to cognitive behavioral therapy (CBT) without CM. Primary outcome measures for cocaine (urine screens) and alcohol use (timeline followback) were collected thrice-weekly during 12 weeks of treatment. Retention in treatment and medication compliance rates were low. Rates of cocaine use and drinks per day did not differ between treatment groups; however naltrexone did reduce frequency of heavy drinking days, as did CBT without CM. Notably, adding CM to CBT did not enhance treatment outcomes. These weak findings suggest that pharmacological and behavioral interventions that have shown efficacy in the treatment of a single drug dependence disorder may not provide the coverage needed when targeting dual drug dependence.
Marijuana is the most commonly used illicit substance, yet among the least studied in medication development research. Cocaine-dependent individuals frequently also use marijuana; however, little is known about the effect of this combined use on treatment presentation.
Background: Marijuana use is prevalent among patients with cocaine dependence and often non-exclusionary in clinical trials of potential cocaine medications. The dual-focus of this study was to (1) examine the moderating effect of baseline marijuana use on response to treatment with levodopa/carbidopa for cocaine dependence; and (2) apply an informative-priors, Bayesian approach for estimating the probability of a subgroup-by-treatment interaction effect. Method: A secondary data analysis of two previously published, double-blind, randomized controlled trials provided complete data for the historical (Study 1: N?=?64 placebo), and current (Study 2: N?=?113) data sets. Negative binomial regression evaluated Treatment Effectiveness Scores (TES) as a function of medication condition (levodopa/carbidopa, placebo), baseline marijuana use (days in past 30), and their interaction. Results: Bayesian analysis indicated that there was a 96% chance that baseline marijuana use predicts differential response to treatment with levodopa/carbidopa. Simple effects indicated that among participants receiving levodopa/carbidopa the probability that baseline marijuana confers harm in terms of reducing TES was 0.981; whereas the probability that marijuana confers harm within the placebo condition was 0.163. For every additional day of marijuana use reported at baseline, participants in the levodopa/carbidopa condition demonstrated a 5.4% decrease in TES; while participants in the placebo condition demonstrated a 4.9% increase in TES. Conclusion: The potential moderating effect of marijuana on cocaine treatment response should be considered in future trial designs. Applying Bayesian subgroup analysis proved informative in characterizing this patient-treatment interaction effect.
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