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Biomedical subjects

Kyle Kampman

Publications and source records attributed to Kyle Kampman.

6 recordsLinked to original sources
PubMed2006

Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial.

CONTEXT: Oral naltrexone can completely antagonize the effects produced by opioid agonists. However, poor compliance with naltrexone has been a major obstacle to the effective treatment of opioid dependence. OBJECTIVE: To evaluate the safety and efficacy of a sustained-release depot formulation of naltrexone in treating opioid dependence. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled, 8-week trial conducted at 2 medical centers. PARTICIPANTS: Sixty heroin-dependent adults. INTERVENTIONS: Participants were stratified by sex and years of heroin use (> or = 5 vs < 5) and then were randomized to receive placebo or 192 or 384 mg of depot naltrexone. Doses were administered at the beginning of weeks 1 and 5. All participants received twice-weekly relapse prevention therapy, provided observed urine samples, and completed other assessments at each visit. MAIN OUTCOME MEASURES: Retention in treatment and percentage of opioid-negative urine samples. RESULTS: Retention in treatment was dose related, with 39%, 60%, and 68% of patients in the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively, remaining in treatment at the end of 2 months. Time to dropout had a significant main effect of dose, with mean time to dropout of 27, 36, and 48 days for the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively. The percentage of urine samples negative for opioids, methadone, cocaine, benzodiazepines, and amphetamine varied significantly as a function of dose. When the data were recalculated without the assumption that missing urine samples were positive, a main effect of group was not found for any drugs tested except cocaine, where the percentage of cocaine-negative urine samples was lower in the placebo group. Adverse events were minimal and generally mild. This formulation of naltrexone was well tolerated and produced a robust, dose-related increase in treatment retention. CONCLUSION: These data provide new evidence of the feasibility, efficacy, and tolerability of long-lasting antagonist treatments for opioid dependence.

Adolescent↗
PubMed2005

Retrospective analyses of pooled data from CREST I and CREST II trials for treatment of cocaine dependence.

AIM: To analyze pooled data from the Cocaine Rapid Evaluation Screening Trial (CREST). Pooling data from these small pilot trials into four major drug classes permitted data exploration for treatment and covariate effects with increased sample size. DESIGN: Small pilot trials were conducted to screen fifteen medications as prospective treatments for cocaine dependence. Studies included a flexible 2-week to 4-week screening/baseline period followed by an 8-week randomized treatment condition. Participants were randomized equally to one of up to three active medications or placebo. SETTING: Five Medications Development Research Units at the five academic centers of University of Cincinnati, New York University, University of Pennsylvania, University of California Los Angeles and Boston University. PARTICIPANTS: The pooled data set consisted of 357 total subjects. Standardized inclusion and exclusion criteria were employed in subject selection to enhance consistency of cocaine-dependent study participants across all sites (see reports on individual trials in this supplement for details). All participants provided at least two urine samples that were positive for cocaine metabolite during a two-week period prior to being randomized. INTERVENTION: All subjects in these trials, those randomized to placebo and active medications, received active treatment in the form of evidence-based cognitive behavioral therapy. MEASURES: Quantitative urine benzoylecgonine (BE), self-report of cocaine use, and total Brief Substance Craving Scale (BSCS) scores were compared between each class of medication and its matched-placebo group. FINDINGS: Regression analysis of pooled data did not identify any statistically significant differences between treatment and matched-placebo for any of the four classes. Exploration of the effects of baseline covariates indicated that gender and African American status were associated significantly with outcome. Female gender was consistently associated with poorer outcomes for medication and placebo groups, while the direction of association between African American status and outcome differed by treatment groups. Retention was also examined: dropout rates may have been somewhat higher for placebo than treatment groups during the early active-treatment period. Classification trees were used to identify characteristics of subjects who were abstinent for at least two weeks during the eight-week trial; only 4.0% of females while 17.9% of males achieved this criterion. CONCLUSIONS: Results presented here may prove useful for planning future clinical trials for therapies targeting cocaine dependence.

Central Nervous System Agents↗
PubMed2004

Adding a nicotine blocking agent to cigarette tapering.

A non-pharmacologic nicotine-blocking agent (Accu Drop; AD) was preliminarily tested in combination with cigarette tapering and brief counseling (C) in a random assignment, double-blind, placebo controlled, 6-week smoking cessation study (n = 60). It was hypothesized that the AD&C group would have higher rates of treatment completion and smoking abstinence than the placebo drop group plus counseling (PD&C). The participants were 37 women and 23 men averaging 24 cigarettes per day along with high Fagerstrom nicotine dependence scores (FTQ approximately 7) and high plasma cotinine levels (> 250ng/ml). There were no significant differences between groups for withdrawal scores, treatment completion (55%), or average number of sessions attended. Point prevalence followup evaluations were obtained 1 week, 1 month, and 6 months post projected treatment completion. Biochemically confirmed abstinence rates at followups did not differ between treatment groups (AD&C = 10%, 13%, 10% vs. PD&C = 3%, 10%, 13%). There is not enough evidence to suggest a Stage II trial.

Adult↗
PubMed2003

A pilot trial of piracetam and ginkgo biloba for the treatment of cocaine dependence.

BACKGROUND: Chronic cocaine use is associated with cognitive deficits that may reduce the effectiveness of psychosocial treatment and promote relapse in newly abstinent cocaine-dependent patients. Nootropic agents, such as piracetam and ginkgo biloba, may improve cognitive function and reduce the incidence of relapse in these patients. METHODS: This was a 10-week, double-blind, placebo-controlled pilot trial involving 44 cocaine-dependent subjects. Subjects received either piracetam (4.8 g/day), ginkgo biloba (120 mg/day), or placebo. Subjects were required to attain abstinence from cocaine during a 2-week baseline phase demonstrated by providing at least one benzoylecgonine (BE)-negative urine toxicology screen. Outcome measures included treatment retention, urine toxicology screens, Clinical Global Impression (CGI) scores, and results from the Addiction Severity Index (ASI). RESULTS: Ginkgo biloba was not superior to placebo in any outcome measure. Piracetam was associated with more cocaine use and lower CGI scores compared to placebo. CONCLUSIONS: Neither piracetam nor ginkgo biloba appears to be a promising medication for the treatment of cocaine dependence.

Adolescent↗
PubMedDate not supplied

Outcome predictors in cocaine dependence treatment trials.

Finding the predictors of outcome in outpatient cocaine dependence treatment trials may be useful for the development of both psychosocial as well as pharmacological treatments for cocaine dependence. Among the most powerful predictors of response to psychosocial treatment are cocaine withdrawal symptom severity and the results of a urine drug screen (UDS) collected at study entry. The present trial seeks to extend these findings by examining outcome predictors in a large number of subjects participating in a series of outpatient cocaine pharmacotherapy trials while selecting three separate criteria to define successful outcome. The ability of several baseline variables were tested to predict treatment outcome in a series of cocaine medication trials that included 402 cocaine-dependent subjects. Predictor variables included results from the baseline Addiction Severity Index (ASI), initial UDS results, and cocaine withdrawal symptom severity at treatment entry, as measured by scores on the Cocaine Selective Severity Assessment (CSSA). Outcome measures included UDS results obtained during the trials and results from the ASI gathered at the end of the trials. Baseline variables that most consistently predicted treatment outcome were the initial UDS results and initial CSSA scores. These findings indicate that baseline UDS results and CSSA scores are powerful predictors of outcome and should be used as stratifying variables in outpatient cocaine medication trials.

Adult↗