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Sublingual buprenorphine/naloxone for chronic pain in at-risk patients: development and pilot test of a clinical protocol
Rosenblum, Andrew; Cruciani, Ricardo A; Strain, Eric C; Cleland, Charles M; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K
OBJECTIVE: Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated patients with pain with nonadherence behaviors. The transition of opioid-treated patients with pain to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. DESIGN: The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full m-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3-6 months with the expectation that they would experience few adverse events (AEs) and report lower pain severity. RESULTS: The three patients on the highest baseline opioid dose (equivalent to 303-450 mg of oral morphine) and the three on the lowest doses (=20 mg) had early AEs when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a 3-month trial. A mixed-effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < 0.01). CONCLUSION: Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing.
PMCID:3630795
PMID: 23264315
ISSN: 1551-7489
CID: 249352
Predictors of practice patterns for lymphedema care among oncology advanced practice nurses
Ryan, Joanne C; Cleland, Charles M; Fu, Mei R
Lymphedema, a debilitating and chronic condition, is considered to be one of the most distressing adverse effects of cancer treatment. The purpose of this study was to understand the practice patterns in lymphedema care and identify predictors influencing those patterns among oncology nurses, with a focus on advanced practice nurses. Random and purposive sampling was utilized to recruit 238 oncology nurses who completed the Web-based study. Participants included advanced practice nurses (nurse practitioners and clinical nurse specialists), nurse navigators/case managers, staff nurses, and directors/managers/coordinators. Data focused on perceived knowledge of and perceived competence in risk reduction, treatment, and self-management of lymphedema and practice patterns in lymphedema care. Actual knowledge of lymphedema care was evaluated. Descriptive, comparative, and regression analyses were performed. The study showed that perceived knowledge and perceived competence were highly correlated. Perceived competence was a predictor of practicing lymphedema care. Advanced practice nurses scored in the midrange for perceived knowledge and perceived competence in risk reduction and self-management, but obtained lower scores in perceived knowledge and perceived competence for treatment. The odds of advanced practice nurses delivering lymphedema care were less than those of staff nurses. This study identifies gaps and opportunities for advanced practice nurses to play an important role in providing lymphedema care, an essential aspect of cancer survivorship.
PMCID:4093356
PMID: 25031960
ISSN: 2150-0878
CID: 2286812
Correlates of Staying Safe Behaviors Among Long-Term Injection Drug Users: Psychometric Evaluation of the Staying Safe Questionnaire
Vazan, P; Mateu-Gelabert, P; Cleland, CM; Sandoval, M; Friedman, SR
We report on psychometric properties of a new questionnaire to study long-term strategies, practices and tactics that may help injection drug users (IDUs) avoid infection with HIV and hepatitis C. Sixty-two long-term IDUs were interviewed in New York City in 2009. Five scales based on a total of 47 items were formed covering the following domains: stigma avoidance, withdrawal prevention, homeless safety, embedding safety within a network of users, and access to resources/social support. All scales (alpha >/= .79) except one (alpha = .61) were highly internally consistent. Seven single-item measures related to drug use reduction and injection practices were also analyzed. All variables were classified as either belonging to a group of symbiotic processes that are not directly focused upon disease prevention but nonetheless lead to risk reduction indirectly or as variables describing prevention tactics in risky situations. Symbiotic processes can be conceived of as unintentional facilitators of safe behaviors. Associations among variables offer suggestions for potential interventions. These Staying Safe variables can be used as predictors of risk behaviors and/or biological outcomes.
PMCID:3402642
PMID: 22038081
ISSN: 1090-7165
CID: 157041
Estimates of the Population Prevalence of Injection Drug Users among Hispanic Residents of Large US Metropolitan Areas
Pouget, Enrique R; Friedman, Samuel R; Cleland, Charles M; Tempalski, Barbara; Cooper, Hannah L F
Little information exists on the population prevalence or geographic distribution of injection drug users (IDUs) who are Hispanic in the USA. Here, we present yearly estimates of IDU population prevalence among Hispanic residents of the 96 most populated US metropolitan statistical areas (MSAs) for 1992-2002. First, yearly estimates of the proportion of IDUs who were Hispanic in each MSA were created by combining data on (1) IDUs receiving drug treatment services in Substance Abuse and Mental Health Services Administration (SAMHSA)'s Treatment Entry Data System, (2) IDUs being tested in the Centers for Disease Control and Prevention (CDC) HIV-Counseling and Testing System, and (3) incident AIDS diagnoses among IDUs, supplemented by (4) data on IDUs who were living with AIDS. Then, the resulting proportions were multiplied by published yearly estimates of the number of IDUs of all racial/ethnic groups in each MSA to produce Hispanic IDU population estimates. These were divided by Hispanic population data to produce population prevalence rates. Time trends were tested using mixed-effects regression models. Hispanic IDU prevalence declined significantly on average (1992 mean = 192, median = 133; 2002 mean = 144, median = 93; units are per 10,000 Hispanics aged 15-64). The highest prevalence rates across time tended to be in smaller northeastern MSAs. Comparing the last three study years to the first three, prevalence decreased in 82% of MSAs and increased in 18%. Comparisons with data on drug-related mortality and hepatitis C mortality supported the validity of the estimates. Generally, estimates of Hispanic IDU population prevalence were higher than published estimates for non-Hispanic White residents and lower than published estimates for non-Hispanic Black residents. Further analysis indicated that the proportion of IDUs that was Hispanic decreased in 52% and increased in 48% of MSAs between 2002 and 2007. The estimates resulting from this study can be used to investigate MSA-level social and economic factors that may have contributed to variations across MSAs and to help guide prevention program planning for Hispanic IDUs within MSAs. Future research should attempt to determine to what extent these trends are applicable to Hispanic national origin subgroups.
PMCID:3368042
PMID: 22411420
ISSN: 1099-3460
CID: 169717
Longitudinal associations between adolescent alcohol use and adulthood sexual risk behavior and sexually transmitted infection in the United States: assessment of differences by race
Khan, Maria R; Berger, Amanda T; Wells, Brooke E; Cleland, Charles M
Objectives. We examined race differences in the longitudinal associations between adolescent alcohol use and adulthood sexually transmitted infection (STI) risk in the United States. Methods. We estimated multivariable logistic regression models using Waves I (1994-1995: adolescence) and III (2001-2002: young adulthood) of the National Longitudinal Study of Adolescent Health (n = 10 783) to estimate associations and assess differences between Whites and African Americans. Results. In adjusted analyses, adolescent alcohol indicators predicted adulthood inconsistent condom use for both races but were significantly stronger, more consistent predictors of elevated partnership levels for African Americans than Whites. Among African Americans but not Whites, self-reported STI was predicted by adolescent report of any prior use (adjusted odds ratio [AOR] = 1.47; 95% confidence interval [CI] = 1.00, 2.17) and past-year history of getting drunk (AOR = 1.53; 95% CI = 1.01, 2.32). Among Whites but not African Americans, biologically confirmed STI was predicted by adolescent report of past-year history of getting drunk (AOR = 1.68; 95% CI = 1.07, 2.63) and consistent drinking (AOR = 1.65; 95% CI = 1.03, 2.65). Conclusions. African American and White adolescent drinkers are priority populations for STI prevention. Prevention of adolescent alcohol use may contribute to reductions in adulthood STI risk.
PMCID:3483900
PMID: 22493999
ISSN: 0090-0036
CID: 166655
Randomized trial of a reentry modified therapeutic community for offenders with co-occurring disorders: Crime outcomes
Sacks, S; Chaple, M; Sacks, JY; McKendrick, K; Cleland, CM
This article describes a randomized study to determine the effectiveness of a reentry modified therapeutic community (RMTC) for offenders with co-occurring substance use and mental disorders (co-occurring disorders or COD). Men with COD, approved for community corrections placement postrelease, were recruited from nine Colorado prisons and stratified according to the type of treatment received while incarcerated (i.e., a prison modified therapeutic community [MTC] program or standard care). When released, each offender was randomly assigned either to the experimental RMTC (E-RMTC) condition (n = 71) or to the control parole supervision and case management (PSCM) condition (n = 56). An intent-to-treat analysis 12 months postprison release showed that the E-RMTC participants were significantly less likely to be reincarcerated (19% vs. 38%), with the greatest reduction in recidivism found for participants who received MTC treatment in both settings. These findings support the RMTC as a stand-alone intervention and provide initial evidence for integrated MTC programs in prison and in aftercare for offenders with COD.
PMID: 21943810
ISSN: 0740-5472
CID: 157042
Observational Studies Versus Randomized Controlled Trials of Behavioral Interventions in Field Settings
Staines, Graham L.; Cleland, Charles M.
ISI:000300743300004
ISSN: 1089-2680
CID: 161197
Modified therapeutic community aftercare for clients triply diagnosed with HIV/AIDS and co-occurring mental and substance use disorders
Sacks, Stanley; McKendrick, Karen; Vazan, Peter; Sacks, Joann Y; Cleland, Charles M
This clinical trial evaluated a modified therapeutic community aftercare (MTC-A) program for a population triply diagnosed with HIV/AIDS, a substance use disorder, and a mental disorder. After six months of MTC residential treatment (MTC-R), subjects were randomly assigned to MTC-A (n=42) or to standard aftercare (C; n=34). Follow-up interviews at six and 12 months assessed eight outcome domains and adherence to prescribed HIV medication. A propensity model was used to re-balance the retrieved sample. At the six-month follow-up, High stratum MTC-A clients (those with greater psychological functioning and stable physical health at baseline) had greater improvement overall and for substance use and mental health than C clients in the same stratum. In contrast, C clients in the Low/Medium stratum (those with poorer psychological functioning and improved physical health) had more favorable outcomes overall and for substance use than their MTC-A counterparts; however, this stratum was not re-balanced effectively. Differences in HIV medication adherence were not detected. Clients with greater psychological functioning and stable health at treatment entry benefit more from the MTC-A program. In view of the potentially progressive nature of HIV, measuring physical and mental health during treatment and controlling for changes could be important in future research.
PMCID:5826656
PMID: 21711215
ISSN: 0954-0121
CID: 157040
Changes in the prevalence of injection drug use among adolescents and young adults in large U.S. metropolitan areas
Chatterjee, Sudip; Tempalski, Barbara; Pouget, Enrique R; Cooper, Hannah L F; Cleland, Charles M; Friedman, Samuel R
Young injection drug users (IDUs) are at risk for acquiring blood-borne diseases like HIV and Hepatitis C. Little is known about the population prevalence of young IDUs. We (1) estimate annual population prevalence rates of young IDUs (aged 15-29) per 10,000 in 95 large U.S. metropolitan statistical areas (MSAs) from 1992 to 2002; (2) assess the validity of these estimates; and (3) explore whether injection drug use among youth in these MSAs began to rise after HAART was discovered. A linear mixed model (LMM) estimated the annual population prevalence of young IDUs in each MSA and described trends therein. The population prevalence of IDUs among youths across 95 MSAs increased from 1996 (mean = 95.64) to 2002 (mean = 115.59). Additional analyses of the proportion of young IDUs using health services suggest this increase may have continued after 2002. Harm reduction and prevention research and programs for young IDUs are needed
PMCID:3299409
PMID: 21739288
ISSN: 1573-3254
CID: 151728
The effects of symptomatic seroma on lymphedema symptoms following breast cancer treatment
Fu, M R; Guth, A A; Cleland, C M; Lima, E D R P; Kayal, M; Haber, J; Gallup, L; Axelrod, D
It has been speculated that symptomatic seroma, or seroma requiring needle aspiration, is one of the risk factors for lymphedema symptoms following breast cancer treatment. These symptoms exert tremendous impact on patients' quality of life and include arm swelling, chest/breast swelling, heaviness, tightness, firmness, pain, numbness, stiffness, or impaired limb mobility. Our aim was to explore if symptomatic seroma affects lymphedema symptoms following breast cancer treatment. Data were collected from 130 patients using a Demographic and Medical Information interview tool, Lymphedema and Breast Cancer Questionnaire, and review of medical record. Arm swelling was verified by Sequential Circumferential Arm Measurements and Bioelectrical Impedance Spectroscopy. Data analysis included descriptive statistics, Chi-squared tests, regression, exploratory factor analysis and exploratory structural equation modeling. Thirty-five patients (27%) developed symptomatic seroma. Locations of seroma included axilla, breast, and upper chest. Significantly, more women with seroma experienced more lymphedema symptoms. A well-fit exploratory structural equation model [X2(79) = 92.15, p = 0.148; CFI = 0.97; TLI = 0.96] revealed a significant unique effect of seroma on lymphedema symptoms of arm swelling, chest/breast swelling, tenderness, and blistering (beta = 0.48, p < 0.01). Patients who developed symptomatic seroma had 7.78 and 10.64 times the odds of developing arm swelling and chest/breast swelling versus those who did not, respectively (p < 0.001). Symptomatic seroma is associated with increased risk of developing lymphedema symptoms following breast cancer treatment. Patients who develop symptomatic seroma should be considered at higher risk for lymphedema symptoms and receive lymphedema risk reduction interventions.
PMID: 22165584
ISSN: 0024-7766
CID: 156358