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Biomedical subjects

P J Fudala

Publications and source records attributed to P J Fudala.

At least 19 recordsLinked to original sources
PubMed1992

A controlled trial of buprenorphine treatment for opioid dependence.

OBJECTIVE: To assess the efficacy of buprenorphine for short-term maintenance/detoxification. DESIGN: A randomized, double-blind, parallel group study comparing buprenorphine, 8 mg/d, methadone, 60 mg/d, and methadone, 20 mg/d, in a 17-week maintenance phase followed by an 8-week detoxification phase. SETTING: Outpatient facilities at the Addiction Research Center, Baltimore, Md. PATIENTS: One hundred sixty-two volunteers seeking treatment for opioid dependence. INTERVENTION: In addition to the medication, counseling using a relapse prevention model was offered but not required. PRIMARY OUTCOME MEASURES: Retention time in treatment, urine samples negative for opioids, and failure to maintain abstinence. RESULTS: Throughout the maintenance phase, retention rates were significantly greater for buprenorphine (42%) than for methadone, 20 mg/d (20%, P less than .04); the percentage of urine samples negative for opioids was significantly greater for buprenorphine (53%, P less than .001) and methadone, 60 mg/d (44%, P less than .04), than for methadone, 20 mg/d (29%). Failure to maintain abstinence during the maintenance phase was significantly greater for methadone, 20 mg/d, than for buprenorphine (P less than .03). During the detoxification phase, no differences were observed between groups with respect to urine samples negative for opioids. For the entire 25 weeks, retention rates for buprenorphine (30%, P less than .01) and methadone, 60 mg/d (20%, P less than .05), were significantly greater than for methadone, 20 mg/d (6%). All treatments were well tolerated, with similar profiles of self-reported adverse effects. The percentages of patients who received counseling did not differ between groups. CONCLUSIONS: Buprenorphine was as effective as methadone, 60 mg/d, and both were superior to methadone, 20 mg/d, in reducing illicit opioid use and maintaining patients in treatment for 25 weeks.

Adult↗
PubMed1992

Weighing up the pros and cons: help-seeking by drug misusers in Baltimore, USA.

Forty drug misusers receiving treatment in Baltimore completed questionnaires, originally administered to drug misusers in London, about their reasons for seeking help and their worries about the treatment. Seeking help was related to the experiences of addiction, loss of control over life and financial and family difficulties. The main fears were of failing treatment. These responses are similar to those obtained in the London group. There was little correlation between objective assessment and subjects' views of their problems. This study illustrates the complexities of coming for treatment and it emphasises the need for social and medical help.

Adult↗
PubMed1992

Development of buprenorphine for the treatment of opioid dependence.

Data from these studies indicate that buprenorphine is efficacious in treating opioid dependence. It was possible to induct heroin addicts rapidly onto buprenorphine without precipitating an opioid withdrawal syndrome. A daily 8-mg SL dosage was sufficient to maintain individuals without producing reports of withdrawal symptoms. When buprenorphine was administered at the above dose every other day, however, mild withdrawal symptoms were reported, and responses to challenges with intravenously given hydromorphone appeared greater than when the challenges were given intramuscularly. From these results, the authors conclude that buprenorphine at this dose should be administered on a daily basis. These results are now being applied to a phase II outpatient clinical trial comparing buprenorphine with methadone.

Adult↗
PubMed1992

Travel and ciguatera fish poisoning.

BACKGROUND: Ciguatera fish poisoning is a distinctive clinical syndrome associated with the consumption of contaminated marine fish. It is endemic in many popular travel destinations, including the Caribbean and Pacific Islands, where travelers are at risk. METHODS: Clinical review of 23 patients (60% were travelers) with ciguatera fish poisoning in whom consultation was provided between 1987 and 1990. RESULTS: Seven patients acquired ciguatera fish poisoning during international travel to the following destinations: Bahamas (n = 4), Dominican Republic (n = 1), British Virgin Islands (n = 1), and United States (n = 1). Suspected fish included grouper, red snapper, and amberjack. Two patients required emergency care, and four patients developed chronic symptoms. Severity was associated with chronicity, duration of peak symptoms, and worsening of symptoms with sexual activity. Chronicity was associated with severity, long latency period, and duration of peak symptoms. The three patients with complete resolution were scuba divers. Amitriptyline was the drug most often providing benefit for chronic symptoms. CONCLUSIONS: Ciguatera fish poisoning is a health risk to travelers to endemic regions, and their risk likely equals that of indigenous population groups. Barracuda should never be eaten, and travelers should exercise caution when considering other fish dishes, notably, grouper and red snapper.

Animals↗
PubMed1992

Background and design of a controlled clinical trial (ARC 090) for the treatment of opioid dependence.

This study represents the largest clinical trial reported to date that demonstrated the efficacy of buprenorphine for opioid dependence treatment (Johnson et al. 1992). Although the study design was adequate to demonstrate differences between treatment groups, there has not been a consensus regarding the most appropriate method for analyzing various outcome measures of this and similar studies. To present a comprehensive review of these methods, other chapters in this monograph focus on various analytical techniques for assessing one of these measures--urine toxicology screens--for illicit opioids.

Adult↗
PubMed1991

Use of naloxone in the assessment of opiate dependence.

All subjects participating in an outpatient study comparing treatments for opiate dependence were given a naloxone challenge to document their level of dependence. Subjects were assessed at 0, 10, 20, and 30 minutes following the administration of intramuscular naloxone (0.4 mg) using an opiate withdrawal assessment scale and measurements of pupillary diameter. Subjects' self reports of daily dollar amounts of opiate use and time since last use were also examined for possible correlation with withdrawal scale scores and pupillary measurements. A significant negative correlation was obtained between pupil diameter and time since last reported use of an opiate. Results indicated that the scale was a reliable indicator of opiate dependence. Ways in which it might be improved are discussed.

Adult↗
PubMed1991

Human pharmacology and abuse potential of nalmefene.

Nalmefene hydrochloride was administered to six male volunteers with histories of opiate abuse using a double-blind, randomized, Latin square design to determine if it produced typical morphine-like effects. A comparison of physiologic and subject- and observer-reported effects was made between morphine, 15 and 30 mg given intramuscularly; nalmefene, 25, 50, and 100 mg given orally; and placebo. Drowsiness or sleepiness was the most common drug effect reported after the administration of each treatment. Only morphine produced miosis and increased subject-reported euphoria and "drug liking." Neither drug increased Addiction Research Inventory subscale scores measuring dysphoria or sedation or produced changes on the Profile of Mood States questionnaire. Adverse effects reported only after the administration of nalmefene included agitation/irritability and muscle tension; these did not appear to be dose related. The data indicated that nalmefene did not produce typical morphine-like effects and has no apparent abuse potential.

Adult↗
PubMed1990

Buprenorphine-induced pupillary effects in human volunteers.

The pupillary effects of the partial opiate agonist buprenorphine were studied in 16 male subjects who were heroin dependent at the time of admission to the study. Sublingual buprenorphine (8 mg) was administered daily for 18 days and continued either daily or on alternate days from study days 19 through 36. On days 37 through 56, all subjects received buprenorphine placebo. Compared to placebo, buprenorphine decreased pupil size and diminished the constriction and dilation velocities of the light reflex. These effects occurred within 5 hours of buprenorphine administration. Following placebo administration during alternate-day dosing of buprenorphine, pupil size increased and constriction and dilation velocities of the light reflex were significantly greater than after buprenorphine administration in the same subjects. This pattern of effects was observed after buprenorphine was discontinued (day 37). The results indicated that buprenorphine has pupillary effects like those of full opiate agonists. The time course of these effects was similar to previously-reported effects of buprenorphine on the electroencephalogram but not to the time course of subjective effects.

Adult↗
PubMed1990

Conditioned aversion after delay place conditioning with amphetamine.

Male, Sprague-Dawley rats received subcutaneous injections of either dextroamphetamine sulfate (AMP; 3.0 mg/kg) or vehicle [VEH (phosphate buffer); 1 ml/kg] immediately before (standard conditioning) or after (delay conditioning) conditioning sessions in a place-conditioning paradigm. AMP was paired for 4 conditioning sessions with one compartment of a three-compartment place-conditioning apparatus; VEH was paired for 4 conditioning sessions with another compartment. Animals were then tested for place preference or aversion by determining the proportion of time spent in each compartment during a 15-minute test session. Standard conditioning with AMP produced a place preference while delay conditioning produced a place aversion. Similar findings had earlier been reported from studies involving conditioned place-preferences and aversions with nicotine. These studies demonstrated that the time of drug administration can be as strong a determinant of place-conditioning effects as the drug itself.

Animals↗
PubMed1990

Safety and side-effects of buprenorphine in the clinical management of heroin addiction.

Sublingual buprenorphine (8 mg) was administered to heroin-dependent addicts daily for 18 days and continued from day 19-day 36 either daily or on alternate days. Final data are reported on 18 subjects. The number of self-reported symptoms reviewed as potential adverse drug reactions ranged from 1 to 88 per participant. None was considered to be related definitely to the study medication, and there were no reporting differences between the two dosing regimens. Forty-five reactions were considered probably related to buprenorphine: sedation/drowsiness (three reports) and constipation (42 reports). It was concluded that these were anticipated drug effects rather than adverse reactions. Although some participants showed increases in serum aminotransferase levels, those increases could not be directly attributed to buprenorphine. We conclude that buprenorphine was well tolerated, but further study is needed in this population to delineate the possible attributable risk of the drug to hepatic dysfunction in this population.

Administration, Sublingual↗
PubMed1990

Use of buprenorphine in the treatment of opioid addiction. II. Physiologic and behavioral effects of daily and alternate-day administration and abrupt withdrawal.

Nineteen heroin-dependent male volunteers were administered buprenorphine sublingually, in ascending daily doses of 2, 4, and 8 mg. They were maintained on 8 mg daily through study day 18. On study days 19 through 36, subjects in group 1 continued to receive burprenorphine daily; subjects in group 2 received buprenorphine or placebo on alternate days. On days 37 through 52, all subjects received placebo. Subjects receiving buprenorphine on alternate days reported significantly greater urge for an opioid, increased dysphoria scores, and pupillary dilation on placebo days. After abrupt termination of buprenorphine, no withdrawal signs were detected with the Himmelsbach scale. However, subjects reported mild-to-moderate opioid withdrawal symptoms, peaking at 3 to 5 and lasting for 8 to 10 days. Daily administration of buprenorphine provided greater control of subtle opioid withdrawal symptoms, but subjects could tolerate a between-dose interval of 48 hours.

Adult↗
PubMed1989

Use of buprenorphine in the treatment of opiate addiction. I. Physiologic and behavioral effects during a rapid dose induction.

A new, rapid dose-induction procedure was used in the evaluation of buprenorphine hydrochloride (buprenorphine) as a treatment for opiate dependence. Nineteen heroin-dependent men were given buprenorphine sublingually in ascending daily doses of 2, 4, and 8 mg and then maintained on 8 mg daily. The observations of the transition from heroin to buprenorphine for the first 4 days are described. During this period, subjects reported significantly elevated ratings of "good effects" and feelings of "overall well-being" and decreased ratings of "overall sickness." Data from subscales of the Addiction Research Center Inventory indicated increasing euphoria and decreasing dysphoria and sedation after buprenorphine administration. Subjects and observers consistently identified buprenorphine as an opiate and not as an opiate antagonist. These findings indicate that a rapid dose induction with buprenorphine is acceptable to heroin-dependent persons and that it causes minimal withdrawal symptoms.

Administration, Sublingual↗
PubMed1989

Sublingual versus subcutaneous buprenorphine in opiate abusers.

To compare the pharmacologic profiles of sublingually and subcutaneously administered buprenorphine, 10 healthy male subjects with histories of opiate abuse were given sublingually administered buprenorphine (1, 2, and 4 mg), subcutaneously administered buprenorphine (1 and 2 mg), and placebo in a double-blind, double-dummy, placebo-controlled study. All active buprenorphine dosages produced a significant degree of miosis but no significant changes in body temperature, blood pressure, or respiratory or heart rate. Buprenorphine produced varying degrees of euphoria related to dose and route of administration but little dysphoria and sedation, as assessed by subscales of the Addiction Research Center Inventory. Subject "liking" for buprenorphine was reported by both observers and subjects. The relative potency of sublingually to subcutaneously administered buprenorphine was calculated for both physiologic and behavioral parameters and found to be approximately two thirds. The results indicated that both sublingual and subcutaneous buprenorphine have a similar profile of effects in opiate abusers.

Administration, Sublingual↗
PubMed1987

Conditioned aversion after delay place conditioning with nicotine.

Rats received subcutaneous injections of either nicotine (NIC; 0.05-0.8 mg/kg) or vehicle [VEH (phosphate buffer); 1 ml/kg] immediately after conditioning sessions in a place-conditioning paradigm (delay conditioning). NIC was paired for three delay-conditioning sessions with one environment of a three-compartment place-conditioning apparatus; VEH was paired with another environment. The subjects were then tested for place preference or aversion by determining the proportion of time spent in each compartment during a 15-min test session. Delay conditioning with NIC only produced a dose-related place aversion (greater time was spent in the VEH-paired chamber on test day). Place aversion was evident when NIC, 0.8 mg/kg, was administered either immediately or 5 min after conditioning sessions but not when given 15 min after conditioning. Chlorisondamine (5 micrograms, lateral ventricle), but not saline, administered 2 weeks prior to delay conditioning with 0.8 mg/kg NIC completely blocked the NIC-induced place aversion. These data suggest that delay conditioning with NIC produces place aversion by a central mechanism. Since standard conditioning (NIC injection immediately before the place-conditioning sessions) with NIC only produced dose-related place preferences (Fudala et al. 1985; Fudala and Iwamoto 1986), the time of administration of the unconditioned stimulus is a strong determinant of the place-conditioning effects of NIC.

Animals↗