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The Tufts Addiction Research Center Inventory--Morphine Benzedrine Group (ARCI-MBG) scale was designed to measure benzodiazepine-induced mood elevation. The reliability and validity of the Tufts ARCI-MBG scale were determined in 64 subjects with a history of alcoholism (HA), a positive history of parental alcoholism, defined as one or both parents meeting DSM-III-R criteria for alcohol dependence (PHP), and matched control subjects. Significant correlations were found for within-day Tufts ARCI-MBG scale scores for all groups and for between-day scores for PHP and matched control subjects. Interitem reliability was significant for pooled baseline scores. For HA subjects, correlations between mean Tufts ARCI-MBG scale and Drug Liking scores that were obtained after either alprazolam or diazepam administration were significant. These results suggest that the Tufts ARCI-MBG scale is a reliable test that is a valid measure of benzodiazepine-induced mood elevation. [ABSTRACT FROM AUTHOR]

BACKGROUND: We examined personality traits (Sociability, Impulsivity, Neuroticism) as mediators of the effects of family history on alcohol outcomes. METHODS: A sample of 485 men reported on family history of alcohol problems in 1973, completed the Eysenck Personality Inventory in 1976, and responded to a survey on alcohol use in 1982. RESULTS: Using structural equation modeling, family history was found to have direct effects on number of drinks per day and on the number of alcohol problems, as well as indirect effects mediated through Neuroticism. There were no effects of Sociability or Impulsivity on either alcohol outcome. CONCLUSIONS: In this sample of older men, family history had both direct and indirect effects, and personality traits found to affect alcohol outcomes were different from those that have been found in younger men. [ABSTRACT FROM AUTHOR]

Abstract Background Patient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF)." Particularly, we identify factors that, according to patient reports, motivated study participation. Methods The RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA) Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview. Results We successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study site (t-test: p < .001). The most frequently reported reason for study participation was some benefit to the patient him/herself. Other reasons included helping others, being grateful to the VA, positive comments by trusted professionals, certain characteristics of the recruiter, and monetary compensation. Conclusions The enrollment rate was low primarily because of travel considerations, but we were able to identify and highlight valuable information for planning recruitment for future similar studies.

Aims: In the current study, nefazodone, an antidepressant with dual action on serotonin and norepinephrine reuptake as well as 5-HT(2A) receptor antagonist effects, was studied in subjects with cocaine dependence and depressive symptoms, to determine its efficacy in reducing cocaine use., Design: An 8-week, double blind, placebo-controlled design was used., Setting: The study was conducted at the Medication Development Research Unit (MDRU) at the VA Boston Healthcare System and the Manhattan Department of Veterans Affairs (DVA) Medical Center., Participants: Subjects (n = 69) met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence and had Hamilton Depression Scores of 12 or higher., Intervention: Subjects were assigned randomly to receive nefazodone 200 mg twice daily (n = 34) or matching placebo (n = 35). All subjects received individual counseling., Measurements: Urinary measurements of benzoylecgonine (BE, three times per week) and self-reports of cocaine use were the primary outcome measures. Secondary outcome measures included assessments of psychiatric functioning, cocaine craving and social functioning., Findings: Median weekly BE declined more rapidly in the nefazodone than in the placebo group. Median urine BE at baseline was, however, significantly greater in nefazodone than in the placebo group. Scores for strength of cocaine craving also decreased more rapidly in the nefazodone group compared to the placebo group. Both groups had equivalent improvement in mood, psychosocial functioning and self-reported cocaine use., Conclusions: These results suggest that nefazodone administration can reduce cocaine craving after it has been administered for several weeks. Although the nefazodone group had a greater rate of decrease in BE levels than the placebo group, the interpretation of this finding is obscured by significant group differences in baseline BE levels.

Aims: The two studies presented here were conducted to assess the efficacy of paroxetine, pentoxifylline, riluzole, venlafaxine and pramipexole as medications for the treatment of cocaine dependence., Design: A multi-arm, modified blinded, placebo-controlled design was used., Setting: The studies were conducted at the Boston VA Healthcare System and the Boston University School of Medicine Medication Development Research Unit (MDRU)., Participants: Participants met criteria for cocaine dependence during a 2-week screening period., Intervention: Following random assignment to one of the treatment groups, subjects received active medication or placebo for 8 weeks in combination with cognitive behavioral counseling. In the first study the efficacy of the antidepressant paroxetine (20 mg daily), the phosphodiesterase inhibitor pentoxifylline (1200 mg daily) and the glutamate release inhibitor riluzole (100 mg daily) was assessed. The antidepressant venlafaxine (150 mg daily) and the dopamine agonist pramipexole (1.5 mg daily) were evaluated in the second study., Measurements: Urine benzoylecgonine (BE) concentrations, self-report of cocaine use and global impression scores served as primary outcome measures. Secondary measures included assessments of cocaine craving and psychiatric functioning. Adverse events were monitored during the treatment period., Findings: None of the active medications produced greater reductions in urine BE concentrations over the treatment period than did placebo. There were trends for BE levels to become reduced in the pentoxifylline group during the first 4 weeks of treatment and for Addiction Severity Index (ASI) drug composite scores to be lower in the pentoxyfylline group at end-point compared to the placebo group. Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications were superior to placebo on these measures. The accuracy of self-reported cocaine use declined over the study period. Overall, the active medications were well tolerated., Conclusions: This study does not support the use of paroxetine, pentoxifylline, riluzole, venlafaxine or pramipexole for the treatment of cocaine dependence. However, these results need to be interpreted with caution because of the small size and lack of homogeneity of the experimental groups.

Aims: The Cocaine Rapid Efficacy Screening Trials (CREST) were designed by the National Institute on Drug Abuse Division of Treatment Research and Development (NIDA, DT R&D) to rapidly screen a number of medications potentially useful for the treatment of cocaine dependence., Design: Each CREST trial was designed to compare several medications in a single trial against an unmatched placebo. The placebo group was included in each trial to avoid the nearly universal positive response to medications seen in open-label trials. In addition, a common set of procedures and outcome measures were employed throughout to increase comparability of results obtained from different trials and from different times., Participants: In all, 18 medications were screened in seven different trials, conducted in four different sites throughout the United States involving 398 cocaine-dependent patients., Findings: Three medications were found to be promising enough to include in subsequent larger trials. Common statistical procedures for evaluating medications were developed to facilitate comparisons across sites and across time. A portion of the data were pooled and analyzed, which yielded some useful insights into cocaine dependence and its treatment. Finally, a review of individual trials together with the pooled analysis revealed several potential improvements for future screening trials., Conclusions: Overall, the CREST trials proved to be useful for rapidly screening medications for treatment of cocaine dependence, but several modifications in design should be made before this framework is applied further.

Aim: Development of effective medications for the treatment of cocaine dependence remains a major priority for the National Institute on Drug Abuse (NIDA) at the National Institutes of Health. The Cocaine Rapid Efficacy Screening Trial (CREST) paradigm was developed by the Division of Treatment Research and Development (DT R&D) at NIDA with the goal of enhancing pilot clinical trial validity when systematically assessing a range of medications and drug classes for potential utility in treatment of cocaine dependence., Design: CREST utilizes a randomized, controlled, parallel group, blinded methodology for comparing one or more marketed medications against a standard, pharmaceutical grade placebo. The trial design is comprised of a flexible 24-week screening/baseline period followed by randomization to an 8-week treatment period., Measures: Standard measures of outcomes for the CREST included urinary benzoylecgonine (primary metabolite of cocaine), retention, cocaine craving, depression, clinical global impression and HIV-risk behaviors. In order to facilitate comparisons of data from the CREST studies across sites, drug classes and time, standardized procedures, measures and psychosocial counseling were used., Results: A total of 19 medications were evaluated in out-patient treatment research clinics in Boston, Cincinnati, Los Angeles, New York and Philadelphia., Conclusions: Findings supported decisions to move forward three medications (cabergoline, reserpine, tiagabine) using full-scale, adequately powered, randomized placebo-controlled trial designs. Lessons learned from the CREST experience continue to shape cocaine pharmacotherapy trial design and execution.

Quetiapine is an atypical antipsychotic that has sedative effects. In this retrospective study, indices of alcohol use were compared for alcohol-dependent subjects who either were (n = 30) or were not (n = 20) treated with quetiapine (25 to 200 mg nightly) for disturbed sleep. Indices examined included total days of abstinence, number of hospitalizations for detoxification, and days to first relapse over 1 year of clinic treatment. Subjects were male veterans. All subjects had a diagnosis of alcohol dependence, and 90% of subjects in each group were also diagnosed with posttraumatic stress disorder. Both treatment groups contained a large number of subjects treated with psychiatric medications other than quetiapine. Significant differences were not found between the groups with respect to mean age, detoxifications undergone during the previous year, frequency of comorbid posttraumatic stress disorder or depression, or antidepressant use. The mean number of days abstinent was significantly greater, and the number of hospitalizations was significantly lower for the quetiapine than for the control group during the period studied. The mean number of days to relapse approached significance for the quetiapine as compared to the control group. This study has the usual limitations of a retrospective review, including the lack of standardized assessments of alcohol use. The results of this study are consistent with the hypothesis that the use of quetiapine to improve disturbed sleep may help alcohol-dependent patients maintain abstinence, although decreased drinking may also be a result of improving posttraumatic stress disorder symptoms or of a direct action of quetiapine to reduce alcohol use.

Increased interest in addiction psychopharmacology has raised unique methodologic issues in the design, conduct, and analysis of outcomes in clinical trials of therapeutic agents for drug dependence. This article summarizes issues raised at a meeting in Palo Alto, California, on November 4, 1996, that was sponsored by the Medication Development Division of the National Institute on Drug Abuse and the Department of Veterans Affairs Cooperative Studies Program to discuss the methodologic issues in clinical trials of cocaine pharmacotherapy.

A recent review of the literature on Post-Traumatic Stress Disorder (PTSD) and the MMPI has shown that all previously published studies have been limited to clinical groups whose trauma occurred in Vietnam combat. The purpose of this study was to test hypotheses that predict higher MMPI and PTSD scale scores among combat veterans who differ in degrees of noncombat traumas. Results support predictions. Those who reported more noncombat traumas attain significantly higher MMPI scores for scales F, Hypochondriasis, Hysteria, Psychopathic Deviate, Psychasthenia, Schizophrenia, Mania, Social Introversion, and an MMPI PTSD score (Keane, Malloy, & Fairbank, 1984). Moreover, noncombat effects are manifested differentially: Combat veterans with higher noncombat trauma evidence greater social withdrawal, whereas noncombat veterans who report higher noncombat trauma are characterized by higher anxiety. MMPI elevations were progressively higher as groups increased in degrees of combat and noncombat trauma: noncombat and low combat trauma veterans were the better adjusted, and combat veterans with higher noncombat trauma were the worst adjusted. Results provide descriptive validity for PTSD as a construct and underscore the importance of assessing frequency and intensity, as well as types of traumas and stresses, in the background histories of substance abusers and other clinical groups as well.