total recall? researchers’ perceptions of the consent process

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Page 1: Total recall? Researchers’ perceptions of the consent process

Abstracts / Drug and Alcohol Dependence 146 (2015) e202–e284 e269

effects of previous nicotine exposure following amphetamine chal-lenge.

Conclusions: Therefore, these results show that while nicotinedoes produce CPP in pre-adolescent rats, it also alters behavior5–7 days later. These changes in behavior may relate to changesin behavior seen in young children following brief exposures tosmoking which have been considered as precursors to smokingdependence.

Financial support: Supported by SUNY Downstate.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.196

Effects of alcohol intake on balance andstability in older adults: A pilot study

Yinghui Duan 1,5, Lisa Barry 2, Jonathan Covault 3,Anne Kenny 3, Cheryl Oncken 3, RichardBohannon 4, James Grady 5, Helen Wu 6

1 Community Medicine & Healthcare, University ofConnecticut Health Center, Farmington, CT, UnitedStates2 Centeron Aging, UCHC, Farmington, CT, UnitedStates3 Medicine, UCHC, Farmington, CT, United States4 Department of Kinesiology, University ofConnecticut, Storrs, CT, United States5 Connecticut Institute for Clinical and TranslationalScience (CICATS), University of Connecticut HealthCenter, Farmington, CT, United States6 Psychiatry, University of Connecticut HealthCenter, Farmington, CT, United States

Aims: Little is known regarding the acute effects of small dosesof alcohol on balance and stability, functions highly associated withfalling, in older adults. Our study assessed balance and stability afteracute intake of a low to moderate dose of alcohol in adults age >65years.

Methods: After being screened and consented, 23 age-and-gender-matched, healthy, current drinkers age >65 were givenapproximately two standard alcoholic drinks adjusted to weight.Balance and stability were measured in 4 conditions – normal sur-face with open and closed eyes and padded surface (to reducetactile input and challenge balance) with open and closed eyes. Lim-its of stability (LOS) were assessed using the Bertec Force Plate atbaseline, i.e., prior to alcohol intake, and at 40 min-intervals up to160 min after alcohol intake.

Results: In this group of age-and-gender matched subjects, wefound no statistical differences in BMI, number of weekly drinks,and assessments of liver function including AST and ALT betweenmen (n = 11) and women (n = 12). The peak breath alcohol con-centrations (BrAC) at 40-min post-alcohol ingestion were 0.032%and 0.030% for women and men, respectively. Overall, after adjus-ting for age and timepoint, higher BrAC in women was significantlyassociated with declined performance in normal open-eye condi-tion (p = 0.02), and in LOS (p < 0.0001), whereas it had no effect inmen.

Conclusions: Our preliminary data indicate that low to mod-erate alcohol intake may negatively affect balance and stabilityin older women, yet may be negligible in men. More research isneeded to replicate the study results.

Financial support: None.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.197

Basal neuroendocrine status and cocainecraving measurements in activecocaine-dependent volunteers at admission andafter 8 weeks of abstinence

Elizabeth A. Ducat, Brenda M. Ray, JasmyneJackson, E. Butelman, Mary Jeanne Kreek

Laboratory of the Biology of Addictive Diseases,Rockefeller University, New York, NY, United States

Aims: To examine the effect of 8 weeks of cocaine abstinenceon neuroendocrine status and subjective cocaine craving in cocainedependent volunteers.

Methods: Sixteen male and female active cocaine dependentsubjects were admitted to the stress-minimized inpatient unitat the Rockefeller University Hospital for an 8-week abstinencestudy. Following admission, subjects completed the Cocaine Crav-ing Questionnaire and baseline neuroendocrine testing, whereblood was sampled for ACTH, cortisol and prolactin, from just priorto a saline placebo i.v. administration and 0–90 min thereafter. Sub-jects lived on the research unit during the 8-week study period, andwere accompanied to an off-site substance abuse counseling pro-gram three times per week. Nine of the sixteen subjects were ableto complete the entire 8 week protocol, at which time a 2nd salineplacebo day and CCQ were obtained Seven of the sixteen subjectswithdrew or were terminated from the study prior to completingthe 8 weeks. Area under the curve (AUC) for ACTH, cortisol andprolactin was calculated and analyzed for all subjects at admission,and 8 weeks later for those completing the study.

Results: No significant neuroendocrine differences were foundbetween subjects completing vs. subjects unable to complete the8 week study. In completers, subjective measures of cocaine crav-ing (CCQ scores) significantly decreased after 8 weeks of inpatientabstinence; however, no differences were seen in plasma ACTH,serum cortisol or prolactin levels between week 0 and week 8.

Conclusions: These results suggest that subjective measures ofcocaine craving as measured by the CCQ decreased over a periodof abstinence under stress-minimized conditions. Of interest, thesetime-dependent decreases in CCQ scores were not accompanied bychanges in stress-responsive hormone levels in this 8 week absti-nence period.

Financial support: NIH-NIDA P50-DA005130 (M.J.K.), NCATSUL1-TR000043 and The Adelson Medical Research Foundation.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.198

Total recall? Researchers’ perceptions of theconsent process

Karen L. Dugosh, David Festinger

Treatment Research Institute, Philadelphia, PA,United States

Aims: Research demonstrates participants’ limited recall ofessential information communicated during the consent process.Despite federal recommendations that consent information shouldbe adequately recalled over the course of a study, many researchershave not adopted these recommendations. This study examinedsubstance abuse researchers’ perceptions of the informed consentprocess and the type of strategies they use to ensure recall of con-sent information.

Methods: We developed a 19-item web-based survey to assess(1) investigator characteristics, (2) area of research, (3) percep-tions about the importance of consent recall, (4) beliefs about howwell participants recall consent information, and (5) strategies theyuse to improve recall. To identify our sample, we conducted a

Page 2: Total recall? Researchers’ perceptions of the consent process

e270 Abstracts / Drug and Alcohol Dependence 146 (2015) e202–e284

search of the NIH RePORTER database. We identified 723 currentlyfunded NIDA and NIAAA investigators who conducted researchrequiring informed consent. We sent a link for the web-based sur-vey to the identified sample. A total of 263 individuals responded(35% response rate) and 233 indicated they conducted human sub-jects research and were eligible for the survey. Respondents wereentered into a drawing for a $200 Amazon gift card.

Results: The majority of respondents conducted experimen-tal behavioral research with vulnerable populations. Most felt itwas “very” (63%) or “somewhat” (31%) important for participantsto recall consent information throughout the study. The majorityfelt that participants were only “moderately” able to recall con-sent information. The most commonly used consent strategies wereproviding copies of consent form (92%), regularly reminding par-ticipants of consent information (58%), and using consent quizzes(30%).

Conclusions: Although most researchers reported that ongoingconsent recall was important, most believed their clients were notable to completely recall this information. In addition, they gener-ally reported using only the most basic consent strategies. Thesefindings support the need for broader implementation of empiri-cally based strategies to improve consent recall in substance abuseresearch.

Financial support: Funded by NIDA grant R01-DA021621.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.199

Drinking during the first two weeks of a clinicaltrial significantly predicts drinking at the end ofthe trial

Kelly E. Dunn, Eric C. Strain

Psychiatry and Behavioral Sciences, Johns HopkinsUniversity, Baltimore, MD, United States

Aims: There is a robust association between early abstinencefrom drugs/cigarettes and long-term abstinence. This study evalu-ated whether this association was also true for alcohol. A secondaryanalysis of the COMBINE data was conducted to evaluate whetherany self-reported drinking during the first 2 weeks of an alcoholtreatment trial significantly predicted drinking at the end of the16-week study.

Methods: Participants who specified abstinence as a treat-ment goal and who completed the 16-week intervention weredichotomized into early abstainer (N = 440) and early drinker(N = 418) groups based on whether they reported 1 or more drinksduring the first 2 weeks of the trial. Drinking was evaluated asnumber of drinking and heavy drinking days.

Results: Participants were 74% Caucasian and 72% male. Over-all, 25% of participants did not drink at all during the study.Early drinkers were more likely to report drinking (100% vs. 52%,p < .001) and heavy drinking (91% vs. 40%, p < .001) during weeks3–16 compared to early abstainers, respectively. Drinking dur-ing the first 2 weeks was significantly correlated with drinking(p < .001) and heavy drinking (p < .001) on the final day of treat-ment. These results were further supported by multivariate logisticregressions that controlled for treatment group, treatment site, andgender, which revealed that drinking and heavy drinking duringthe final week of treatment was 3.6 (p < .001) and 3.2 (p < .001)-foldmore likely, respectively, among early drinkers vs. early abstain-ers. Finally, early drinkers reported resuming drinking (4.4 vs. 23.2days; p < .001), and heavy drinking (10 vs. 20 days, p < .001) morequickly compared to early abstainers.

Conclusions: Overall, these data indicate that alcohol use withinthe first 2 weeks of a treatment trial is highly predictive of

drinking and heavy drinking throughout the trial and at the endof the study. This information can be used to identify patients forwhom additional resources and support may be needed early intheir treatment, and may help increase the efficacy of alcohol treat-ment interventions.

Financial support: Supported by DA023186.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.200

ADHD as risk factor for early onset and laterseverity of illicit substance use: An acceleratedgateway model

Eugene M. Dunne, Lauren Hearn, Jonathan J. Rose,W.W. Latimer

Clinical and Health Psychology, University of Florida,Gainesville, FL, United States

Aims: The primary study aim was to assess history of ADHD asa risk factor for early onset of drug use and severity of current druguse among adult heroin and cocaine users. It was hypothesized thatadult drug users with a history of ADHD would display a similarpattern of initiation but with an earlier age of onset compared todrug users without ADHD.

Methods: A secondary data analysis of participants enrolled inthe NIDA-funded NEURO-HIV Epidemiologic Study in Baltimore,Maryland. The sample included 984 current drug using adults(M age = 35.3, SD = 9.8; 51.9% male; 61.4% African American). Par-ticipants were community recruited and completed an HIV-riskbehavior interview. Chi-square and independent t-test analyzeddemographics and drug use behaviors between ADHD and non-ADHD groups. Logistic regressions assessed gender differences inthe association of ADHD and heavy smoking.

Results: ADHD history was endorsed by 135 (13.7%) par-ticipants, with males being more likely to report a diagnosis(males = 16.4%, females = 10.9%). Individuals with ADHD were sig-nificantly younger, more likely to be male, and more likely to beCaucasian. As hypothesized, the ADHD group reported a signifi-cantly younger age of onset for all substances (cigarettes, alcohol,marijuana, cocaine, and heroin). Mean differences in age of onsetranged from 1.5 years (marijuana) to 2.7 years (injection cocaine).Participants with a history of ADHD were also significantly morelikely to be current heavy cigarette smokers (�2 = 15.4, p < .001),marijuana users (�2 = 14.25, p < .001), and heroin and/or cocaineinjectors (�2 = 6.98, p = .008). There was a significant relationshipbetween heavy smoking and ADHD in females only, after adjus-ting for drug use and demographics (AOR = 3.37, 95%CI: 1.04–10.95,p < .05).

Conclusions: ADHD may result in an accelerated gateway tosubstance use and should be an important consideration for druguse prevention and intervention efforts.

Financial support: This project was supported by NIDAR01DA14498.

http://dx.doi.org/10.1016/j.drugalcdep.2014.09.201