Effects of galantamine on smoking behavior and cognitive performance in treatment-seeking smokers prior to a quit attempt.

OBJECTIVE: Drugs that enhance cholinergic transmission have demonstrated promise treating addictive disorders. Galantamine, an acetylcholinesterase inhibitor, may reduce cigarette smoking in otherwise healthy treatment-seeking smokers. METHODS: The current study is a double-blind, placebo-controlled, study that randomized daily smokers (n = 60) to receive one of two doses of galantamine extended release (8 or 16 mg/day), or a placebo treatment. Participants completed a smoking choice task as well as study measures and cognitive tasks in the laboratory and daily life using ecological momentary assessment. Analysis focused on smoking behavior and satisfaction, cognitive performance, and decision to smoke prior to a quit attempt. RESULTS: Linear mixed models demonstrated that, compared with placebo, both doses of galantamine reduced smoking in a laboratory choice task (p = 0.006) and decreased urine cotinine levels, but not self-reported cigarettes, during the pre-quit period (p = 0.007). Treatment had minimal effect on smoking satisfaction or cognitive performance. CONCLUSIONS: The results suggest that galantamine reduces nicotine intake but it is unlikely that galantamine improves cognitive performance in otherwise healthy, treatment-seeking smokers. Larger randomized clinical trials can determine if galantamine adjunctive to addiction treatment can improve smoking treatment outcomes.

Emotion dysregulation and negative affect: Laboratory and EMA investigations in smokers.

INTRODUCTION: Difficulties in emotion regulation are associated with addictive behaviors, including smoking. Difficulties in emotion regulation may underlie large, rapid changes in negative affect that can increase likelihood of relapse. We investigated the association between emotion regulation ability and negative affect in smokers assessed both in the laboratory and in the field using Ecological Momentary Assessment. METHODS: Adult community smokers (N = 44) carried a personal digital assistant (PDA) for two weeks and were instructed to complete assessments of negative affect multiple times per day. Participants were instructed that they could smoke as much or as little as they liked. The Difficulties in Emotion Regulation Scale (DERS) and the Positive and Negative Affect Schedule (PANAS) were completed at three lab visits. RESULTS: Participants with higher average DERS scores reported greater negative affect at lab visits. When a participant reported a DERS score at a lab visit higher than their individual average, they also reported higher negative affect at that lab visit. Participants with higher baseline DERS scores reported more labile negative affect during EMA than those with lower baseline DERS scores, and they also reported a higher maximum level of negative affect during EMA. DISCUSSION AND CONCLUSIONS: Overall, the findings suggest that changes in emotion regulation are associated with negative affect and that emotion regulation ability is related to both the intensity and lability of negative affect. A better understanding of momentary changes in emotion regulation and negative affect may lead to improved interventions for preventing substance use relapse.

The effect of N-acetylcysteine and working memory training on cocaine use, craving and inhibition in regular cocaine users: correspondence of lab assessments and Ecological Momentary Assessment.

INTRODUCTION: Effective treatment for cocaine use disorder should dampen hypersensitive cue-induced motivational processes and/or strengthen executive control. Using a randomized, double-blind, placebo-controlled intervention, the primary aim of this study was to investigate the effect of N-Acetylcysteine (NAC) and working memory (WM)-training to reduce cocaine use and craving and to improve inhibition assessed in the laboratory and during Ecological Momentary Assessment (EMA). The second aim was to examine correspondence between laboratory and EMA data. METHODS: Twenty-four of 38 cocaine-using men completed a 25-day intervention with 2400mg/day NAC or placebo and WM-training as well as two lab-visits assessing cocaine use, craving and inhibition (Stop Signal task). Additionally, cocaine use, craving and cognition (Stroop task) were assessed using EMA during treatment, with 26 participants completing 819 assessments. RESULTS: Cocaine problems according to the Drug Use Disorder Identification Test (DUDIT) decreased more after NAC than after placebo, and the proportion of cocaine-positive urines at lab-visit 2 was lower in the NAC group. No NAC effects were found on craving. For cocaine use and craving, results from the lab data were generally similar to EMA results. NAC also showed some effects on cognitive control: improved inhibition assessed with the Stop Signal task in the lab, and decreased classic Stroop performance during EMA. There were no significant effects of number of completed WM-training sessions. CONCLUSIONS: Overall this study revealed mixed findings regarding the treatment of cocaine use disorders with NAC and WM-training. The effect of NAC on inhibition should be further investigated.

Pro-tobacco advertisement exposure among African American smokers: An ecological momentary assessment study.

INTRODUCTION: Many African Americans live in communities with a disproportionately high density of tobacco advertisements compared to Whites. Some research indicates that point-of-sale advertising is associated with impulse purchases of cigarettes and smoking. Ecological Momentary Assessment (EMA) can be used to examine associations between tobacco advertisement exposure and smoking variables in the natural environment. METHODS: Non-treatment seeking African American smokers were given a mobile device for 2weeks (N=56). They were prompted four times per day and responded to questions about recent exposure to tobacco advertisements. Participants were also asked to indicate the number of cigarettes smoked, and if they made any purchase, or an impulse purchase, since the last assessment. Linear mixed models (LMMs) analyzed between- and within-subject associations between exposure and outcomes. RESULTS: Participants reported seeing at least one advertisement on 33% of assessments. Of those assessments, they reported seeing menthol advertisements on 87% of assessments. Between-subject analyses revealed that participants who on average saw more advertisements were generally more likely to report purchasing cigarettes and to purchase cigarettes on impulse. Within-subject analyses revealed that when an individual participant reported seeing more advertisements than usual they were more likely to have reported purchasing cigarettes, making an impulse purchase and smoking more cigarettes during the same period, but not the subsequent time period. CONCLUSIONS: Many African American smokers are frequently exposed to pro-tobacco marketing. Advertisement exposure is cross-sectionally associated with impulse purchases and smoking. Future research should assess prospective associations in more detail.

Effect of attentional retraining on cognition, craving, and smoking in African American smokers.

African American cigarette smokers have lower rates of cessation than Whites and live in communities with a higher number of tobacco advertisements. Exposure to smoking cues may promote smoking and undermine cessation. It may be possible to reduce attention to smoking cues ("attentional bias"). In this study, we investigated the effect of attentional retraining (AR) on attentional bias and smoking in African American smokers. Nontreatment- seeking African American smokers (N = 64) were randomly assigned to an AR or control condition. Participants were given a mobile device for 2 weeks and prompted to complete up to 3 AR (or control) trainings per day. Participants completed assessments of attentional bias, craving, and smoking both in the lab and in the field. Participants in the AR and control conditions completed an average of 29.07 AR (SD = 12.48) and 30.61 control training tasks (SD = 13.07), respectively. AR reduced attentional bias assessed in the laboratory, F(1, 126) = 9.20, p = .003, and field, F(1, 374) = 6.18, p = .01. This effect generalized to new stimuli, but not to new tasks. AR did not significantly reduce craving or biological measures of smoking. Smoking assessed on the mobile device declined over days in the AR group, F(1, 26) = 10.95, p = .003, but not in the control group, F(1, 27) = 0.02, p = .89. Two weeks of AR administered on a mobile device reduced attentional bias in African American smokers and had mixed effects on smoking. (PsycINFO Database Record

Effect of Brief Mindfulness Practice on Self-Reported Affect, Craving, and Smoking: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment.

INTRODUCTION: Despite efficacious pharmacological and behavioral treatments, most smokers attempt to quit without assistance and fail to quit. Mindfulness practice may be useful in smoking cessation. METHODS: This ecological momentary assessment (EMA) study was a pilot parallel group randomized controlled trial of a brief mindfulness practice (Brief-MP) intervention on self-reported smoking behavior delivered to smokers on a Personal Digital Assistant (PDA) in the field. Adult community smokers (N = 44) were randomly assigned to a Brief-MP (n = 24) or Control (sham meditation; n = 20) group. Participants were instructed to smoke as much or as little as they liked. Participants carried a PDA for 2 weeks and were instructed to initiate 20 minutes of meditation (or control) training on the PDA daily, completing an assessment of cognitive and affective processes immediately afterwards. Additionally, they completed assessments at random times up to four times per day. Primary outcome variables were negative affect, craving, and cigarettes smoked per day, all self-reported. RESULTS: Thirty-seven participants provided EMA data totaling 1874 assessments. Linear Mixed Model analyses on EMA data revealed that Brief-MP (vs. Control) reduced overall negative affect, F(1, 1798) = 13.8, P = .0002; reduced craving immediately post-meditation, (Group × Assessment Type interaction, F(2, 1796) = 12.3, P = .0001); and reduced cigarettes smoked per day over time (Group × Day interaction, F(1, 436) = 5.50, P = .01). CONCLUSIONS: Brief-MP administered in the field reduced negative affect, craving, and cigarette use, suggesting it may be a useful treatment.

Do comorbid fibromyalgia diagnoses change after a functional restoration program in patients with chronic disabling occupational musculoskeletal disorders?

STUDY DESIGN: A retrospective study of prospectively collected data. OBJECTIVE: To determine whether comorbid fibromyalgia, identified in patients with chronic disabling occupational musculoskeletal disorders (CDOMDs), resolves with a functional restoration program (FRP). SUMMARY OF BACKGROUND DATA: Fibromyalgia involves widespread bodily pain and tenderness to palpation. In recent studies, 23% to 41% of patients with CDOMDs entering an FRP had comorbid fibromyalgia, compared with population averages of 2% to 5%. Few studies have examined whether fibromyalgia diagnoses resolve with any treatment, and none have investigated diagnosis responsiveness to an FRP. METHODS: A consecutive cohort of patients with CDOMDs (82% with spinal disorders and all reporting chronic spinal pain) and comorbid fibromyalgia (N = 117) completed an FRP, which included quantitatively directed exercise progression and multimodal disability management. Diagnosis responsiveness, evaluated at discharge, created 2 groups: those who retained fibromyalgia and those who did not. These groups were compared with chronic regional lumbar pain only patients (LO group, n = 87), lacking widespread pain and fibromyalgia. RESULTS: Of the patients with comorbid fibromyalgia, 59% (n = 69) retained the fibromyalgia diagnosis (RFM group) and 41% (n = 48) lost the fibromyalgia diagnosis (LFM group) at discharge. Although all 3 groups reported decreased pain intensity, disability, and depressive symptoms from admission to discharge, RFM patients reported higher symptom levels than the LFM and LO groups at discharge. The LFM and LO groups were statistically similar. At 1-year follow-up, LO patients demonstrated higher work retention than both fibromyalgia groups (P < 0.03). CONCLUSION: Despite a significant comorbid fibromyalgia prevalence in a cohort of patients with CDOMDs entering an FRP, 41% of patients with an initial fibromyalgia diagnosis no longer met diagnostic criteria for fibromyalgia at discharge and were indistinguishable from LO patients on pain, disability, and depression symptoms. However, both fibromyalgia groups (LFM and RFM) had lower work retention than LO patients 1 year later, suggesting that an FRP may suppress symptoms of fibromyalgia in a subset of patients, but prolonged fibromyalgia-related disability may be more difficult to overcome. LEVEL OF EVIDENCE: 2.

Facilitating surgical decisions for patients who are uncertain: a pilot surgical option process within an interdisciplinary functional restoration program.

BACKGROUND CONTEXT: For chronic pain patients, recovery may be slowed by indecisiveness over optional surgery. These patients may be delayed from participating in interdisciplinary functional restoration (FR), pending resolution of the surgical decision. Uncertainty about surgery or rehabilitation leads to delayed recovery. A surgical option process (SOP) was developed to permit patients with chronic disabling occupational musculoskeletal disorders to enter FR, make a final determination halfway through treatment, and return to complete rehabilitation after surgery, if surgery was elected. PURPOSE: This study assessed the frequency with which an FR program can resolve an uncertain surgical option. It also assessed program completion rate and 1-year post-program outcomes for subgroups that decline surgery, request and receive surgery, or request surgery but are denied by surgeon or insurance carrier. STUDY DESIGN: Retrospective study of a consecutive cohort. PATIENT SAMPLE: A cohort of 44 consecutively treated chronic disabling occupational musculoskeletal disorder patients were admitted to an FR program and identified as candidates for a surgical procedure but were either ambivalent about undergoing surgery, had a difference of opinion by two or more surgeons, or were denied a surgical request by an insurance carrier. Patients attended half (10 full day visits) of an FR program before making their own final determination to pursue a request or decline surgery. OUTCOME MEASURES: Patients were assessed on surgical requests and whether surgery was ultimately performed, program completion status after the surgical determination, demographic variables, and 1-year outcomes on work status, additional surgery, and other health utilization measures. METHODS: Patients became part of the SOP on program entry and were included in the study if they participated in a surgical-decision interview halfway through the program. Those who elected to decline surgery (DS) completed the program without delay, but those requesting surgery were placed on hold from the program while consultation and preauthorization steps took place. Those requesting surgery, but denied (RSD), and those undergoing surgery (US) were given the opportunity to complete FR following postoperative physical therapy or resolution of the surgical re-evaluation process. RESULTS: There were 32 DS patients (73%), indicating that a large majority of patients declined the surgery that was still being considered when offered participation in the SOP. Of the 12 patients wanting a surgery, there were four US patients who received surgery previously denied (9% of cohort), and eight RSD patients (18% of cohort). Patients from the DS group completed the FR program at an 88% rate, as did 75% of US patients. However, despite an opportunity to re-enter and complete rehab, only 50% of RSD patients completed the FR option. Overall, patients who persistently sought surgery, contrary to the recommendations of a surgeon, had poorer outcomes. These 1-year post-FR outcomes included lower return-to-work and work retention rates, with higher rates of treatment seeking from new providers (resulting in higher rates of post-discharge surgery) and higher rates of recurrent injury claims after work return. CONCLUSIONS: A SOP tied to participation in an interdisciplinary FR program resolves uncertainty regarding surgical options in a high proportion of cases, resulting in a large majority declining surgery and completing the FR program. Timely surgery is also promoted decisively when needed. Findings suggest that patients who persistently seek surgery, contrary to the recommendations of a surgeon, frequently fail to complete FR and have poorer outcomes overall.

Lumbar surgery in work-related chronic low back pain: can a continuum of care enhance outcomes?

BACKGROUND CONTEXT: Systematic reviews of lumbar fusion outcomes in purely workers' compensation (WC) patient populations have indicated mixed results for efficacy. Recent studies on lumbar fusions in the WC setting have reported return-to-work rates of 26% to 36%, reoperation rates of 22% to 27%, and high rates of persistent opioid use 2 years after surgery. Other types of lumbar surgery in WC populations are also acknowledged to have poorer outcomes than in non-WC. The possibility of improving outcomes by employing a biopsychosocial model with a continuum of care, including postoperative functional restoration in this "at risk" population, has been suggested as a possible solution. PURPOSE: To compare objective socioeconomic and patient-reported outcomes for WC patients with different lumbar surgeries followed by functional restoration, relative to matched comparison patients without surgery. STUDY DESIGN/SETTING: A prospective cohort study of chronic disabling occupational lumbar disorder (CDOLD) patients with WC claims treated in an interdisciplinary functional restoration program. PATIENT SAMPLE: A consecutive cohort of 564 patients with prerehabilitation surgery completed a functional restoration and was divided into groups based on surgery type: lumbar fusion (F group, N=331) and nonfusion lumbar spine surgery (NF group, N=233). An unoperated comparison group was matched for length of disability (U group, N=349). OUTCOME MEASURES: Validated patient-reported measures of pain, disability, and depression were administered pre- and postrehabilitation. Socioeconomic outcomes were collected via a structured 1-year "after" interview. METHODS: All patients completed an intensive, medically supervised functional restoration program combining quantitatively directed exercise progression with a multimodal disability management approach. The writing of this article was supported in part by National Institutes of Health Grant 1K05-MH-71892; no conflicts of interest are noted among the authors. RESULTS: The F group had a longer length of disability compared with the NF and U groups (M=31.6, 21.7, and 25.9 months, respectively, p<.001). There were relatively few statistically significant differences for any socioeconomically relevant outcome among groups, with virtually identical postrehabilitation return-to-work (F=81%, NF=84%, U=85%, p=.409). The groups differed significantly after surgery on diagnosis of major depressive disorder and opioid dependence disorder as well as patient-reported depressive symptoms and pain intensity prerehabilitation. However, no significant differences in patient-reported outcomes were found postrehabilitation. Prerehabilitation opioid dependence disorder significantly predicted lower rates of work return and work retention as well as higher rates of treatment-seeking behavior. Higher levels of prerehabilitation perceived disability and depressive symptoms were significant risk factors for poorer work return and retention outcomes. CONCLUSIONS: Lumbar surgery in the WC system (particularly lumbar fusion) have the potential achieve positive outcomes that are comparable to CDOLD patients treated nonoperatively. This study suggests that surgeons have the opportunity to improve lumbar surgery outcomes in the WC system, even for complex fusion CDOLD patients with multiple prior operations, if they control postoperative opioid dependence and prevent an excessive length of disability. Through early referral of patients (who fail to respond to usual postoperative care) to interdisciplinary rehabilitation, the surgeon determining this continuum of care may accelerate recovery and achieve socioeconomic outcomes of relevance to the patient and WC jurisdiction through the combination of surgery and postoperative rehabilitation.

The effect of prior lumbar surgeries on the flexion relaxation phenomenon and its responsiveness to rehabilitative treatment.

BACKGROUND CONTEXT: Abnormal pretreatment flexion-relaxation in chronic disabling occupational lumbar spinal disorder patients has been shown to improve with functional restoration rehabilitation. Little is known about the effects of prior lumbar surgeries on flexion-relaxation and its responsiveness to treatment. PURPOSE: To quantify the effect of prior lumbar surgeries on the flexion-relaxation phenomenon and its responsiveness to rehabilitative treatment. STUDY DESIGN/SETTING: A prospective cohort study of chronic disabling occupational lumbar spinal disorder patients, including those with and without prior lumbar spinal surgeries. PATIENT SAMPLE: A sample of 126 chronic disabling occupational lumbar spinal disorder patients with prior work-related injuries entered an interdisciplinary functional restoration program and agreed to enroll in this study. Fifty-seven patients had undergone surgical decompression or discectomy (n=32) or lumbar fusion (n=25), and the rest had no history of prior injury-related spine surgery (n=69). At post-treatment, 116 patients were reevaluated, including those with prior decompressions or discectomies (n=30), lumbar fusions (n=21), and no surgery (n=65). A comparison group of 30 pain-free control subjects was tested with an identical assessment protocol, and compared with post-rehabilitation outcomes. OUTCOME MEASURES: Mean surface electromyography (SEMG) at maximum voluntary flexion; subject achievement of flexion-relaxation (SEMG≤3.5 µV); gross lumbar, true lumbar, and pelvic flexion ROM; and a pain visual analog scale self-report during forward bending task. Identical measures were obtained at pretreatment and post-treatment. METHODS: Patients entered an interdisciplinary functional restoration program, including a quantitatively directed, medically supervised exercise process and a multimodal psychosocial disability management component. The functional restoration program was accompanied by a SEMG-assisted stretching training program, designed to teach relaxation of the lumbar musculature during end-range flexion, thereby improving or normalizing flexion-relaxation and increasing lumbar flexion ROM. At 1 year after discharge from the program, a structured interview was used to obtain socioeconomic outcomes. RESULTS: At pre-rehabilitation, the no surgery group patients demonstrated significantly better performance than both surgery groups on absolute SEMG at maximum voluntary flexion and on true lumbar flexion ROM. Both surgery groups were less likely to achieve flexion-relaxation than the no surgery patients. The fusion patients had reduced gross lumbar flexion ROM and greater pain during bending compared with the no surgery patients, and reduced true lumbar flexion ROM compared with the discectomy patients. At post-rehabilitation, all groups improved substantially on all measures. When post-rehabilitation measures were compared with the pain-free control group, with gross and true lumbar ROM corrected by 8° per spinal segment fused, there were no differences between any of the patient groups and the pain-free control subjects on spinal ROM and only small differences in SEMG. The three groups had comparable socioeconomic outcomes at 1 year post-treatment in work retention, health-care utilization, new injury, and new surgery. CONCLUSIONS: Despite the fact that the patients with prior surgery demonstrated greater pretreatment SEMG and ROM deficits, functional restoration treatment, combined with SEMG-assisted stretching training, was successful in improving all these measures by post-treatment. After treatment, both groups demonstrated ROM within anticipated limits, and the majority of patients in all three groups successfully achieved flexion-relaxation. In a chronic disabling occupational lumbar spinal disorder cohort, surgery patients were nearly equal to nonoperated patients in responding to interdisciplinary functional restoration rehabilitation on measures investigated in this study, achieving close to normal performance measures associated with pain-free controls. The responsiveness and final scores shown in this study suggests that flexion-relaxation may be a useful, objective diagnostic tool to measure changes in physical capacity for chronic disabling occupational lumbar spinal disorder patients.

Facilitating unequivocal and durable decisions in workers' compensation patients eligible for elective orthopedic surgery.

UNLABELLED: Timely intervention and recovery is beneficial to patients with chronic disabling occupational musculoskeletal disorders. Therefore, a surgical option process was developed for use in a functional restoration program (FRP) to allow chronic disabling occupational musculoskeletal disorder patients who were undecided about elective orthopedic surgery to participate in interdisciplinary rehabilitation, rather than suspending treatment, until the surgical option could be resolved. A consecutive cohort of 295 chronic disabling occupational musculoskeletal disorder patients with an unresolved surgical option was admitted to an FRP and their surgical preference at FRP midpoint was determined. The majority of patients declined surgery (n = 164) and were invited to complete the FRP. The remainder elected to pursue surgery and either underwent surgery (n = 43) or had their surgical request denied (n = 38). In the post-FRP year, only .8% of patients reversed their original decision and underwent surgery. Patients whose surgical preferences were accommodated (ie, the declined-surgery/underwent-surgery groups) demonstrated significant psychosocial improvement and excellent socioeconomic outcomes, which were similar to those of FRP patients without a surgical option. Patients whose request for surgery was denied had poorer outcomes than the other groups, but still outperformed FRP dropouts. This suggests that the addition of a formal surgical option process to an interdisciplinary FRP facilitated the surgical decision-making process and helped prevent delayed recovery. PERSPECTIVE: This study introduces a surgical option process to improve outcomes for patients with chronic disabling occupational musculoskeletal disorders who are undecided about elective orthopedic surgery. The addition of a surgical option process to interdisciplinary rehabilitation may resolve surgical indecision, improve outcomes, promote psychosocial recovery, and facilitate progression to Maximum Medical Improvement.