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Improvement in psychiatric symptoms during interim buprenorphine treatment
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Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
in combination with phendimetrazine, preventing further work to examine the efficacy of phendimetrazine for cocaine use disorder. The aim of this study is to determine the cardiovascular and behavioral effects of acute intranasal cocaine doses during chronic phendimetrazine treatment. We hypothesized that cocaine would be well tolerated during phendimetrazine maintenance. Methods: Ten human cocaine users will complete the study, with 9 completing to date. Subjects are maintained on ascending oral phendimetrazine doses (0, 70, 140 and 210 mg/day). After at least 7 maintenance days at each dose, subjects received ascending doses of intranasal cocaine (0, 10, 20, 40 and 80 mg), separated by 90 min, within a single session. Repeated measures analysis of variance were used to analyze peak effect data. Results: During placebo maintenance, cocaine produced prototypical cardiovascular and subjective effects (e.g., increased blood pressure and ratings of like drug). The acute cardiovascular effects of cocaine alone were not clinically significant. Phendimetrazine dose-dependently enhanced the peak heart rate produced by low cocaine doses, but these effects were also not clinically significant. No unexpected or serious adverse events occurred. Phendimetrazine did not produce any other effects on its own, nor did it alter the subjective effects of cocaine. Conclusions: Cocaine is safe and well tolerated during maintenance on a range of phendimetrazine doses. Given this safety profile, the reduced abuse potential of phendimetrazine and promising preclinical research, future human laboratory studies and clinical trials should evaluate the efficacy of phendimetrazine for reducing cocaine use. Financial support: R01 DA 036553. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.540 Racial and ethnic differences in substance use diagnoses, comorbid psychiatric disorders and treatment initiation among HIV-positive and HIV-negative women Erik David Storholm 1,3,2,∗ , Michael Silverberg 2 , Derek Satre 2,3 1
Rand Corporation, Santa Monica, CA, United States Kaiser Permanente, Oakland, CA, United States 3 Psychiatry, UCSF, San Francisco, CA, United States 2
Aims: Access to substance use disorder (SUD) treatment is a critical issue for women with HIV. This study examined racial/ethnic differences in SUD diagnoses, comorbid psychiatric diagnoses, and predictors of SUD treatment initiation among a racial/ethnically diverse sample of HIV-positive women (N = 228) and a demographically similar cohort of HIV-negative women (N = 693). Methods: Diagnoses and service utilization data were obtained from electronic health records of members of a large integrated healthcare system in Northern California. Results: HIV-positive women were less likely to initiate SUD treatment. Among HIV-positive women, being diagnosed with an amphetamine use disorder, comorbid depressive disorder, and anxiety disorder were associated with being white, while cocaine diagnosis was associated with being black. Among HIV-negative women, a diagnosis of alcohol SUD, comorbid depressive disorder, and comorbid anxiety disorder were associated with being white; diagnosis of cannabis SUD and cocaine SUD were associated with being black; and a diagnosis of amphetamine SUD and depressive disorder were associated with being Latina. Multivariable logistic regression models showed that alcohol, cannabis, and opiate diagnoses were predictive of SUD treatment initiation for both cohorts, while amphetamine SUD, comorbid depressive disorder, and being
white or Latina were predictive of SUD treatment initiation for HIV-negative, but not HIV-positive women. Conclusions: Findings suggest that clinicians need to be aware of differences in substances of abuse, comorbid psychiatric disorders, and to consider social and structural issues that may contribute to HIV and racial/ethnic differences in SUD treatment initiation among women. Financial support: This study is supported in part by a research grant from Pfizer with additional funding for Dr. Storholm provided by a National Institute of Drug Abuse training grant (T32 DA007250). http://dx.doi.org/10.1016/j.drugalcdep.2016.08.541 Improvement in psychiatric symptoms during interim buprenorphine treatment Joanna Mayers Streck 1,∗ , Taylor A. Ochalek 1 , Bryce Hruska 2 , Jacob D. Pusey 2 , Stacey C. Sigmon 2 1 Psychological Science, University of Vermont, Burlington, VT, United States 2 Psychiatry, University of Vermont, Burlington, VT, United States
Aims: Prevalence of affective disorders among opioid abusers exceeds the general population. While depression, anxiety and other symptoms often improve upon entry into opioid treatment, this has been seen with treatments that involve psychosocial counseling. Here we examine changes in psychiatric symptoms during a randomized clinical trial evaluating a novel treatment for waitlisted opioid-dependent (OD) adults involving buprenorphine (BUP) maintenance with minimal monitoring and no counseling. Methods: OD adults are randomized to one of two 12-week conditions: Interim Buprenorphine Treatment (IBT) consists of BUP maintenance with bi-monthly visits and the remaining doses dispensed via computerized device. Waitlist Control (WLC) participants remain on the WL of their local clinic. We examined betweenand within-group differences on the Brief Symptom Inventory (BSI) and Beck Depression Inventory (BDI-II) at intake and Weeks 4, 8 and 12. Results: 28 participants have been randomized to IBT (n = 14) and WLC (n = 14) conditions. Participants are 33 years old and 57% male, 61% endorse heroin as their primary drug, and 82% have a lifetime history of IV drug use. On the Global Severity Index (GSI) subscale of the BSI, IBT participants randomized are reporting lower levels of psychological distress at Weeks 4 and 8 relative to WLC participants (F(3,69) = 3.24, p’s < .05). IBT participants’ GSI scores are also decreasing over time (p < .01), with no change in WLC participants. On the BDI, IBT participants report lower depression scores at Weeks 4, 8, and 12 vs. WLC participants (F(3,69) = 6.22, p < .01). BDI scores are also significantly decreasing over time in IBT participants (p < .01) vs. no change in WLC participants. Conclusions: Preliminary data suggest that IBT, without counseling or psychsocial support, may be associated with reductions in psychiatric distress among waitlisted OD adults. For the 2016 meeting, we will present data from the completed randomized trial of 70 participants. Financial support: NIDA R34DA037385 T32 DA007242. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.542
Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
in combination with phendimetrazine, preventing further work to examine the efficacy of phendimetrazine for cocaine use disorder. The aim of this study is to determine the cardiovascular and behavioral effects of acute intranasal cocaine doses during chronic phendimetrazine treatment. We hypothesized that cocaine would be well tolerated during phendimetrazine maintenance. Methods: Ten human cocaine users will complete the study, with 9 completing to date. Subjects are maintained on ascending oral phendimetrazine doses (0, 70, 140 and 210 mg/day). After at least 7 maintenance days at each dose, subjects received ascending doses of intranasal cocaine (0, 10, 20, 40 and 80 mg), separated by 90 min, within a single session. Repeated measures analysis of variance were used to analyze peak effect data. Results: During placebo maintenance, cocaine produced prototypical cardiovascular and subjective effects (e.g., increased blood pressure and ratings of like drug). The acute cardiovascular effects of cocaine alone were not clinically significant. Phendimetrazine dose-dependently enhanced the peak heart rate produced by low cocaine doses, but these effects were also not clinically significant. No unexpected or serious adverse events occurred. Phendimetrazine did not produce any other effects on its own, nor did it alter the subjective effects of cocaine. Conclusions: Cocaine is safe and well tolerated during maintenance on a range of phendimetrazine doses. Given this safety profile, the reduced abuse potential of phendimetrazine and promising preclinical research, future human laboratory studies and clinical trials should evaluate the efficacy of phendimetrazine for reducing cocaine use. Financial support: R01 DA 036553. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.540 Racial and ethnic differences in substance use diagnoses, comorbid psychiatric disorders and treatment initiation among HIV-positive and HIV-negative women Erik David Storholm 1,3,2,∗ , Michael Silverberg 2 , Derek Satre 2,3 1
Rand Corporation, Santa Monica, CA, United States Kaiser Permanente, Oakland, CA, United States 3 Psychiatry, UCSF, San Francisco, CA, United States 2
Aims: Access to substance use disorder (SUD) treatment is a critical issue for women with HIV. This study examined racial/ethnic differences in SUD diagnoses, comorbid psychiatric diagnoses, and predictors of SUD treatment initiation among a racial/ethnically diverse sample of HIV-positive women (N = 228) and a demographically similar cohort of HIV-negative women (N = 693). Methods: Diagnoses and service utilization data were obtained from electronic health records of members of a large integrated healthcare system in Northern California. Results: HIV-positive women were less likely to initiate SUD treatment. Among HIV-positive women, being diagnosed with an amphetamine use disorder, comorbid depressive disorder, and anxiety disorder were associated with being white, while cocaine diagnosis was associated with being black. Among HIV-negative women, a diagnosis of alcohol SUD, comorbid depressive disorder, and comorbid anxiety disorder were associated with being white; diagnosis of cannabis SUD and cocaine SUD were associated with being black; and a diagnosis of amphetamine SUD and depressive disorder were associated with being Latina. Multivariable logistic regression models showed that alcohol, cannabis, and opiate diagnoses were predictive of SUD treatment initiation for both cohorts, while amphetamine SUD, comorbid depressive disorder, and being
white or Latina were predictive of SUD treatment initiation for HIV-negative, but not HIV-positive women. Conclusions: Findings suggest that clinicians need to be aware of differences in substances of abuse, comorbid psychiatric disorders, and to consider social and structural issues that may contribute to HIV and racial/ethnic differences in SUD treatment initiation among women. Financial support: This study is supported in part by a research grant from Pfizer with additional funding for Dr. Storholm provided by a National Institute of Drug Abuse training grant (T32 DA007250). http://dx.doi.org/10.1016/j.drugalcdep.2016.08.541 Improvement in psychiatric symptoms during interim buprenorphine treatment Joanna Mayers Streck 1,∗ , Taylor A. Ochalek 1 , Bryce Hruska 2 , Jacob D. Pusey 2 , Stacey C. Sigmon 2 1 Psychological Science, University of Vermont, Burlington, VT, United States 2 Psychiatry, University of Vermont, Burlington, VT, United States
Aims: Prevalence of affective disorders among opioid abusers exceeds the general population. While depression, anxiety and other symptoms often improve upon entry into opioid treatment, this has been seen with treatments that involve psychosocial counseling. Here we examine changes in psychiatric symptoms during a randomized clinical trial evaluating a novel treatment for waitlisted opioid-dependent (OD) adults involving buprenorphine (BUP) maintenance with minimal monitoring and no counseling. Methods: OD adults are randomized to one of two 12-week conditions: Interim Buprenorphine Treatment (IBT) consists of BUP maintenance with bi-monthly visits and the remaining doses dispensed via computerized device. Waitlist Control (WLC) participants remain on the WL of their local clinic. We examined betweenand within-group differences on the Brief Symptom Inventory (BSI) and Beck Depression Inventory (BDI-II) at intake and Weeks 4, 8 and 12. Results: 28 participants have been randomized to IBT (n = 14) and WLC (n = 14) conditions. Participants are 33 years old and 57% male, 61% endorse heroin as their primary drug, and 82% have a lifetime history of IV drug use. On the Global Severity Index (GSI) subscale of the BSI, IBT participants randomized are reporting lower levels of psychological distress at Weeks 4 and 8 relative to WLC participants (F(3,69) = 3.24, p’s < .05). IBT participants’ GSI scores are also decreasing over time (p < .01), with no change in WLC participants. On the BDI, IBT participants report lower depression scores at Weeks 4, 8, and 12 vs. WLC participants (F(3,69) = 6.22, p < .01). BDI scores are also significantly decreasing over time in IBT participants (p < .01) vs. no change in WLC participants. Conclusions: Preliminary data suggest that IBT, without counseling or psychsocial support, may be associated with reductions in psychiatric distress among waitlisted OD adults. For the 2016 meeting, we will present data from the completed randomized trial of 70 participants. Financial support: NIDA R34DA037385 T32 DA007242. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.542