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Does craving predict substance use for different substance use disorders? An ecological momentary assessment study in patients with alcohol, tobacco, cannabis and heroin dependence
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Abstracts / Drug and Alcohol Dependence 140 (2014) e169–e251
Long-acting cocaine esterase (LACE): Assessing the treatment approach Edward M. Sellers, M.K. Romach DL Global Partners Inc. and University of Toronto, Toronto, ON, Canada Aims: No medications have been approved for the treatment of cocaine dependence. The aim of this work was to determine the need for and commercial viability of a high turn-over cocaine esterase with high specificity and selectivity with activity for 2–4 weeks after subcutaneous injection for treatment of cocaine dependence. Methods: The Technology Transfer Office, University of Michigan requested an independent assessment of the commercial viability of this treatment approach based in part on Collins GT et al., Neuropsychopharmacology. 2012; 37:1092–1103. Thirteen internationally recognized clinical, policy and research leaders in the addiction field participated in a structured phone interview. Six were former CPDD Awardees. Results: Direct quotes – Need: “no benefit from medications; little benefit from outpatient treatment; some benefit from inpatient treatment; but nothing works”. LACE would be a “substantial advance” and “preferred treatment” if patients would take for at least 6 months. “It takes 2 years to get your life back”. Advantages: “solves the compliance problem” and “removes the reinforcing effects of cocaine” “so over time other interventions can work”. Target patients: “Any one who was motivated”; approvable indication and label “relapse prevention”. Reimbursement: “would follow as it has for buprenorphine and naltrexone”. “Higher functioning professionals with a lot to lose would pay directly”; “Accountable/Managed Care and HMOs”. “The Affordable Care Act will help”. Challenges: “patient acceptance”; “antibody formation”; “polydrug use”; “injection volume”; “need physician involvement”; “few funding sources”; “regulatory requirements”; “cost of medication”. Market size: Probably $200–350 M 3 years after approval and launch. Conclusions: LACE is potentially a superior treatment approach to cocaine dependence, commercially viable and addresses an unmet public health need. Substantial development challenges exist. Government support, an expedited efficacy development plan focused on safety combined with post-marketing studies might be considered. Financial support: Technology Transfer Office, University of Michigan. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.562 Eating high fat chow increases sensitivity of female rats to indirect-acting but not direct-acting dopamine receptor agonists Katherine M. Serafine 1 , T.A. Bentley 1 , A.E. Grenier 1 , C.P. France 1,2 1
Pharmacology, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States 2 Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States Aims: Diet can impact sensitivity to drugs that act indirectly (i.e. cocaine) or directly (i.e. quinpirole) on dopamine receptors. Eating high fat chow increases sensitivity of female but not male rats to cocaine-induced locomotion and sensitization. Eating high fat chow increases sensitivity of male rats to quinpirole-induced yawning and results in insulin resistance; it is not known whether this diet has similar effects in females.
Methods: Female Sprague-Dawley rats had free or restricted access (i.e., body weight matched to standard chow fed controls) to high fat chow (34.3% fat) or free access to standard chow (5.7% fat). Results: Quinpirole (0.0032–0.32 mg/kg) dose-dependently induced hypothermia and modest rates of yawning. Despite the development of insulin resistance within just 10 days of eating high fat chow, quinpirole dose–response curves for yawning and hypothermia were unchanged over 7 weeks of access to high fat chow (both groups) or standard chow. Rats eating high fat chow were more sensitive to cocaine-induced (1–17.8 mg/kg) locomotion; however, rats eating standard chow also became sensitive following repeated administration of cocaine. Conclusions: That eating high fat chow increased sensitivity of female rats to indirect-acting, but not direct-acting dopamine receptor agonists suggests that eating high fat food might increase vulnerability to abuse drugs like cocaine, particularly among females. Financial support: CPF is supported by the NIDA Senior Scientist Award (K05 DA017918). http://dx.doi.org/10.1016/j.drugalcdep.2014.02.563 Does craving predict substance use for different substance use disorders? An ecological momentary assessment study in patients with alcohol, tobacco, cannabis and heroin dependence F. Serre 1,3 , M. Fatseas 1,3 , J. Swendsen 2 , Marc Auriacombe 1,3 1
Addiction Psychiatry, University Bordeaux/CNRS USR 3413, Bordeaux, France 2 CNRS UMR 5287 INCIA, University Bordeaux, Bordeaux, France 3 CH Ch. Perrens et CHU de Bordeaux, Bordeaux, France Aims: The objective of this study was to assess substancedependent patients in their natural environment using Ecological Momentary Assessment (EMA) to examine the prospective association between craving and substance use. Methods: A total of 132 participants beginning treatment for addiction were recruited from an outpatient treatment center and completed 2 weeks of computerized ambulatory monitoring of daily life experiences. The main substance of dependence was alcohol (n = 39), opiates (n = 32), tobacco (n = 32), or cannabis (n = 29). Patients were asked to describe in real-time their experience of craving and substance use. Data were analyzed using hierarchical linear models (HLM). Results: Craving intensity was strongly predictive of use of the substance that initiated treatment, whether substance use was measured during the same assessment ( = .429, p < 10.4), or prospectively over the subsequent 3-h period ( = .137, p = 0.002). When the prospective models were adjusted for initial substance use, craving remained a significant predictor of substance use over the subsequent 3-h period ( = .137, p = 0.002). These effects were equivalent for men and women, and did not differ by type of substance use disorder. This association was no longer significant for substance use 6 h later ( = .035, p > 0.05). Substance use was also examined as a predictor of later craving intensity, but the association was not significant when adjusting for initial craving levels. Conclusions: This study highlights the central role of craving in determining substance use during quit attempts for a wide variety of substances (legal/illegal, stimulant/sedative).
Abstracts / Drug and Alcohol Dependence 140 (2014) e169–e251
Financial support: PHRC 2006, MILDT 2010, CRA 2009, PRACNRS-CHU 2008, CNRS ATIP.
Age trends in abuse calls to poison centers involving prescription opioids
http://dx.doi.org/10.1016/j.drugalcdep.2014.02.564
Stevan G. Severtson 1 , B. Bucher-Bartelson 1 , Richard C. Dart 1,2
Content validation of the prescription opioid misuse, abuse, and diversion (MAD) instrument in the chronic pain patient population Beatrice Setnik 1 , C.L. Roland 1 , K.S. Coyne 2 , A.I. Barsdorf 3 1
Pfizer Inc, Cary, NC, United States 2 United BioSource Corporation, Bethesda, MD, United States 3 Pfizer Inc, New York, NY, United States Aims: Despite the growing problem of prescription opioid misuse, abuse, and diversion (MAD) in society, the prevalence of MAD in the pain patient population is not clear. Since there are no instruments that measure MAD in this patient population, a novel, self-report MAD Instrument has been developed. This instrument assesses tampering methods, overconsumption use by unintended routes of administration, and diversion. The instrument queries the motives behind these behaviors in order to classify them as either misuse or abuse. The MAD Instrument consists of several questions with multiple-choice options, and several questions where patients rate their concerns regarding prescription opioids on an 11-point (0 = not at all to 10 = extremely worried) numeric rating scale. This study assessed the content validity and patient interpretation of the MAD Instrument. Methods: Patients with chronic pain, who were at low risk for prescription opioid abuse and were currently taking opioids for optimal analgesia (≥30 days) have undergone 2 rounds of 1:1 cognitive interviews (round 1, n = 9; round 2, n = 11). Participants also completed sociodemographic and Brief Pain Inventory questionnaires. Results: Patient age ranged from 25 to 76 years, 60% were female, and 80% white. Overall, 17 (85%) patients reported feeling comfortable answering the questions honestly. Five (25%) patients stated concerns regarding confidentiality and legal consequences when completing the questionnaire via internet and 3 did not have internet access. Six (30%) did not understand the term “opioid”; the use of “strong pain medication” was clearer. Participants understood the meaning of each question and were not offended. Participants were able to answer questions with the given response options. For reasons of misuse/abuse, obtaining pain relief quicker or better were suggested as reasons to include. Conclusions: Overall, the patients understood the MAD Instrument and could answer its questions. Financial support: This study was sponsored by Pfizer Inc. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.565
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Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, United States 2 University of Colorado-Denver School of Medicine, Aurora, CO, United States Aims: The purpose of this study was to examine correlates and differences in the peak age in years of intentional abuse calls to poison centers mentioning different classes of prescription opioids. Methods: Data from the RADARS® System Poison Center program were used. Mentions of prescription opioid drug classes by intentional abuse cases from the 1st quarter of 2010 through the 2nd quarter of 2012 were summed by age between the ages of 11 years and 69 years. A linear regression model tested the association between the age with the greatest number of mentions (peak age) for each drug and the log of number of individuals filling a prescription for that drug. A negative binomial regression was used to fit a growth curve to each prescription opioid class to examine differences in age trends by drug. Results: Findings suggest a statistically significant (R2 = 0.56, p = 0.032) inverse association between peak age of intentional abuse calls to poison centers and drug availability. Hydrocodone, oxycodone, and tramadol were the most available drugs and had peak abuse ages under 22. Methadone and hydromorphone were less available and had peak abuse ages over 23. Growth curve modeling yielded statistically significant differences in age trends of intentional abuse exposures by drug class. Differences in the total number of abuse exposure mentions between drugs were greatest prior to age 20. Conclusions: Younger abusers who are more likely to be in the early stages of drug abuse are likely to abuse opioid medications that are readily available. Most intentional abuse calls involve cases under the age of 30 and primarily involve hydrocodone, oxycodone, and tramadol. After age 20, differences between drug classes are less pronounced. Financial support: The RADARS® System is part of Denver Health and Hospital Authority, a division of the state of Colorado. It is supported by subscription from pharmaceutical manufacturers. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.566 The effects of the interaction between body weight and depression on adolescent and emerging adult alcohol use M.S. Sferra, Ashley Herrick, Krista Lange, Sneha Thamotharan, S. Fields Psychology, Texas A&M University, College Station, TX, United States Aims: Researchers have suggested that obese individuals consume alcohol at a lower rate than that of the general population, and that alcohol dependence can be linked to depression. However, seemingly counter-intuitively, obesity has also been associated with depression. The present study aimed to address these findings by examining whether body weight and depression interact in such a way as to effect alcohol use in adolescents. Methods: We used a two-way Analysis of Variance (ANOVA) to examine the data gathered from participants concerning their frequency of alcohol use, weight status (Healthy weight or Overweight/Obese) via their body mass index, and self-reported levels
Abstracts / Drug and Alcohol Dependence 140 (2014) e169–e251
Long-acting cocaine esterase (LACE): Assessing the treatment approach Edward M. Sellers, M.K. Romach DL Global Partners Inc. and University of Toronto, Toronto, ON, Canada Aims: No medications have been approved for the treatment of cocaine dependence. The aim of this work was to determine the need for and commercial viability of a high turn-over cocaine esterase with high specificity and selectivity with activity for 2–4 weeks after subcutaneous injection for treatment of cocaine dependence. Methods: The Technology Transfer Office, University of Michigan requested an independent assessment of the commercial viability of this treatment approach based in part on Collins GT et al., Neuropsychopharmacology. 2012; 37:1092–1103. Thirteen internationally recognized clinical, policy and research leaders in the addiction field participated in a structured phone interview. Six were former CPDD Awardees. Results: Direct quotes – Need: “no benefit from medications; little benefit from outpatient treatment; some benefit from inpatient treatment; but nothing works”. LACE would be a “substantial advance” and “preferred treatment” if patients would take for at least 6 months. “It takes 2 years to get your life back”. Advantages: “solves the compliance problem” and “removes the reinforcing effects of cocaine” “so over time other interventions can work”. Target patients: “Any one who was motivated”; approvable indication and label “relapse prevention”. Reimbursement: “would follow as it has for buprenorphine and naltrexone”. “Higher functioning professionals with a lot to lose would pay directly”; “Accountable/Managed Care and HMOs”. “The Affordable Care Act will help”. Challenges: “patient acceptance”; “antibody formation”; “polydrug use”; “injection volume”; “need physician involvement”; “few funding sources”; “regulatory requirements”; “cost of medication”. Market size: Probably $200–350 M 3 years after approval and launch. Conclusions: LACE is potentially a superior treatment approach to cocaine dependence, commercially viable and addresses an unmet public health need. Substantial development challenges exist. Government support, an expedited efficacy development plan focused on safety combined with post-marketing studies might be considered. Financial support: Technology Transfer Office, University of Michigan. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.562 Eating high fat chow increases sensitivity of female rats to indirect-acting but not direct-acting dopamine receptor agonists Katherine M. Serafine 1 , T.A. Bentley 1 , A.E. Grenier 1 , C.P. France 1,2 1
Pharmacology, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States 2 Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States Aims: Diet can impact sensitivity to drugs that act indirectly (i.e. cocaine) or directly (i.e. quinpirole) on dopamine receptors. Eating high fat chow increases sensitivity of female but not male rats to cocaine-induced locomotion and sensitization. Eating high fat chow increases sensitivity of male rats to quinpirole-induced yawning and results in insulin resistance; it is not known whether this diet has similar effects in females.
Methods: Female Sprague-Dawley rats had free or restricted access (i.e., body weight matched to standard chow fed controls) to high fat chow (34.3% fat) or free access to standard chow (5.7% fat). Results: Quinpirole (0.0032–0.32 mg/kg) dose-dependently induced hypothermia and modest rates of yawning. Despite the development of insulin resistance within just 10 days of eating high fat chow, quinpirole dose–response curves for yawning and hypothermia were unchanged over 7 weeks of access to high fat chow (both groups) or standard chow. Rats eating high fat chow were more sensitive to cocaine-induced (1–17.8 mg/kg) locomotion; however, rats eating standard chow also became sensitive following repeated administration of cocaine. Conclusions: That eating high fat chow increased sensitivity of female rats to indirect-acting, but not direct-acting dopamine receptor agonists suggests that eating high fat food might increase vulnerability to abuse drugs like cocaine, particularly among females. Financial support: CPF is supported by the NIDA Senior Scientist Award (K05 DA017918). http://dx.doi.org/10.1016/j.drugalcdep.2014.02.563 Does craving predict substance use for different substance use disorders? An ecological momentary assessment study in patients with alcohol, tobacco, cannabis and heroin dependence F. Serre 1,3 , M. Fatseas 1,3 , J. Swendsen 2 , Marc Auriacombe 1,3 1
Addiction Psychiatry, University Bordeaux/CNRS USR 3413, Bordeaux, France 2 CNRS UMR 5287 INCIA, University Bordeaux, Bordeaux, France 3 CH Ch. Perrens et CHU de Bordeaux, Bordeaux, France Aims: The objective of this study was to assess substancedependent patients in their natural environment using Ecological Momentary Assessment (EMA) to examine the prospective association between craving and substance use. Methods: A total of 132 participants beginning treatment for addiction were recruited from an outpatient treatment center and completed 2 weeks of computerized ambulatory monitoring of daily life experiences. The main substance of dependence was alcohol (n = 39), opiates (n = 32), tobacco (n = 32), or cannabis (n = 29). Patients were asked to describe in real-time their experience of craving and substance use. Data were analyzed using hierarchical linear models (HLM). Results: Craving intensity was strongly predictive of use of the substance that initiated treatment, whether substance use was measured during the same assessment ( = .429, p < 10.4), or prospectively over the subsequent 3-h period ( = .137, p = 0.002). When the prospective models were adjusted for initial substance use, craving remained a significant predictor of substance use over the subsequent 3-h period ( = .137, p = 0.002). These effects were equivalent for men and women, and did not differ by type of substance use disorder. This association was no longer significant for substance use 6 h later ( = .035, p > 0.05). Substance use was also examined as a predictor of later craving intensity, but the association was not significant when adjusting for initial craving levels. Conclusions: This study highlights the central role of craving in determining substance use during quit attempts for a wide variety of substances (legal/illegal, stimulant/sedative).
Abstracts / Drug and Alcohol Dependence 140 (2014) e169–e251
Financial support: PHRC 2006, MILDT 2010, CRA 2009, PRACNRS-CHU 2008, CNRS ATIP.
Age trends in abuse calls to poison centers involving prescription opioids
http://dx.doi.org/10.1016/j.drugalcdep.2014.02.564
Stevan G. Severtson 1 , B. Bucher-Bartelson 1 , Richard C. Dart 1,2
Content validation of the prescription opioid misuse, abuse, and diversion (MAD) instrument in the chronic pain patient population Beatrice Setnik 1 , C.L. Roland 1 , K.S. Coyne 2 , A.I. Barsdorf 3 1
Pfizer Inc, Cary, NC, United States 2 United BioSource Corporation, Bethesda, MD, United States 3 Pfizer Inc, New York, NY, United States Aims: Despite the growing problem of prescription opioid misuse, abuse, and diversion (MAD) in society, the prevalence of MAD in the pain patient population is not clear. Since there are no instruments that measure MAD in this patient population, a novel, self-report MAD Instrument has been developed. This instrument assesses tampering methods, overconsumption use by unintended routes of administration, and diversion. The instrument queries the motives behind these behaviors in order to classify them as either misuse or abuse. The MAD Instrument consists of several questions with multiple-choice options, and several questions where patients rate their concerns regarding prescription opioids on an 11-point (0 = not at all to 10 = extremely worried) numeric rating scale. This study assessed the content validity and patient interpretation of the MAD Instrument. Methods: Patients with chronic pain, who were at low risk for prescription opioid abuse and were currently taking opioids for optimal analgesia (≥30 days) have undergone 2 rounds of 1:1 cognitive interviews (round 1, n = 9; round 2, n = 11). Participants also completed sociodemographic and Brief Pain Inventory questionnaires. Results: Patient age ranged from 25 to 76 years, 60% were female, and 80% white. Overall, 17 (85%) patients reported feeling comfortable answering the questions honestly. Five (25%) patients stated concerns regarding confidentiality and legal consequences when completing the questionnaire via internet and 3 did not have internet access. Six (30%) did not understand the term “opioid”; the use of “strong pain medication” was clearer. Participants understood the meaning of each question and were not offended. Participants were able to answer questions with the given response options. For reasons of misuse/abuse, obtaining pain relief quicker or better were suggested as reasons to include. Conclusions: Overall, the patients understood the MAD Instrument and could answer its questions. Financial support: This study was sponsored by Pfizer Inc. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.565
e203
1
Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, United States 2 University of Colorado-Denver School of Medicine, Aurora, CO, United States Aims: The purpose of this study was to examine correlates and differences in the peak age in years of intentional abuse calls to poison centers mentioning different classes of prescription opioids. Methods: Data from the RADARS® System Poison Center program were used. Mentions of prescription opioid drug classes by intentional abuse cases from the 1st quarter of 2010 through the 2nd quarter of 2012 were summed by age between the ages of 11 years and 69 years. A linear regression model tested the association between the age with the greatest number of mentions (peak age) for each drug and the log of number of individuals filling a prescription for that drug. A negative binomial regression was used to fit a growth curve to each prescription opioid class to examine differences in age trends by drug. Results: Findings suggest a statistically significant (R2 = 0.56, p = 0.032) inverse association between peak age of intentional abuse calls to poison centers and drug availability. Hydrocodone, oxycodone, and tramadol were the most available drugs and had peak abuse ages under 22. Methadone and hydromorphone were less available and had peak abuse ages over 23. Growth curve modeling yielded statistically significant differences in age trends of intentional abuse exposures by drug class. Differences in the total number of abuse exposure mentions between drugs were greatest prior to age 20. Conclusions: Younger abusers who are more likely to be in the early stages of drug abuse are likely to abuse opioid medications that are readily available. Most intentional abuse calls involve cases under the age of 30 and primarily involve hydrocodone, oxycodone, and tramadol. After age 20, differences between drug classes are less pronounced. Financial support: The RADARS® System is part of Denver Health and Hospital Authority, a division of the state of Colorado. It is supported by subscription from pharmaceutical manufacturers. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.566 The effects of the interaction between body weight and depression on adolescent and emerging adult alcohol use M.S. Sferra, Ashley Herrick, Krista Lange, Sneha Thamotharan, S. Fields Psychology, Texas A&M University, College Station, TX, United States Aims: Researchers have suggested that obese individuals consume alcohol at a lower rate than that of the general population, and that alcohol dependence can be linked to depression. However, seemingly counter-intuitively, obesity has also been associated with depression. The present study aimed to address these findings by examining whether body weight and depression interact in such a way as to effect alcohol use in adolescents. Methods: We used a two-way Analysis of Variance (ANOVA) to examine the data gathered from participants concerning their frequency of alcohol use, weight status (Healthy weight or Overweight/Obese) via their body mass index, and self-reported levels