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Opioid-Related Disorders clinical trials

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NCT ID: NCT03918850 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Medication Treatment for Opioid Use Disorder in Expectant Mothers

MOMs
Start date: August 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

NCT ID: NCT03911739 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

MOMs-INO
Start date: October 2020
Phase: Phase 3
Study type: Interventional

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.

NCT ID: NCT03911466 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

MOMs-CMA
Start date: August 2019
Phase: Phase 3
Study type: Interventional

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

NCT ID: NCT03891628 Recruiting - Clinical trials for Opioid-Related Disorders

Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants

mABC
Start date: August 13, 2018
Phase: N/A
Study type: Interventional

This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation compared to infants of parents who receive the control intervention.

NCT ID: NCT03859778 Recruiting - Clinical trials for Opioid-Related Disorders

Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence

STUD_TOX
Start date: January 14, 2019
Phase:
Study type: Observational

The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks. Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients under OST is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed OST in France. Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with opioid-dependent patients, even though these pharmacists have received education in the management of addictions during their studies. Indeed, it can consider that these courses should help to better understand the addictive disease both in its nosological / semiological and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction education on pharmacists' perception of opioid dependence. In this perspective, it would be interesting to focus on pharmacy students. The objective of this study will be to evaluate the perception by pharmacy students of opioid dependent patients. Investigator would like to know if pharmacy students consider opioid addiction to be an illness and whether having taken education on drug use and addictions changes this perception.

NCT ID: NCT03857139 Not yet recruiting - Smoking Cessation Clinical Trials

Opioids and Smoking Cessation

Start date: January 2020
Phase: Phase 4
Study type: Interventional

The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit1. For example, those less successful in quitting smoking may be more nicotine dependent or more likely to suffer from substance use, psychiatric, or medical conditions. In line with this perspective, smoking prevalence has stabilized in the US, presumably because the remaining population has become increasingly representative of those "at-risk smokers" who are unable to quit2. Emerging evidence suggests that persons who suffer from opioid misuse, defined as opioid use without a prescription, at a dose or frequency higher than prescribed, or for a non-medical purpose (e.g., getting high),3 may constitute such a high-risk group. Opioid misuse affects greater than 16% adults who use opioids4 and up to 29% of those with chronic pain.5 The prevalence of tobacco smoking in this group may exceed twice that observed in the general population, and smokers misusing opioids are almost twice as likely to be dependent on nicotine6,7. Yet, the role of opioid misuse in periods of early abstinence and smoking cessation has yet to be explored. The main objective of the present proposal is to fill existing gaps in knowledge by examining the extent to which opioid misuse is associated with decreased success during early smoking abstinence and over the course of an attempt to quit smoking, and to identify mediators and moderators of opioid-smoking relations in this context. This contribution is clinically-significant from a public health standpoint because it will directly guide the development of novel psychosocial/behavioral smoking cessation interventions to help this high-risk population of smokers quit by targeting unique vulnerability processes that result in poor cessation outcomes.

NCT ID: NCT03845699 Recruiting - Clinical trials for Opioid-Related Disorders

Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose

Start date: February 28, 2019
Phase:
Study type: Observational

RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and severe hypoventilation (respiratory depression) due to an opioid overdose. The purpose of this clinical trial is to develop/validate diagnostic algorithms capable of detecting/predicting the onset of hypoventilation induced by a controlled intravenous infusion of fentanyl. The wearable sensor and algorithms will provide a series of alerts and alarms to the person, caregiver, and/or emergency personnel.

NCT ID: NCT03842137 Not yet recruiting - Opioid Dependence Clinical Trials

tDCS to Decrease Opioid Relapse

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with heroin dependence, in the first week of prescribed buprenorphine, will be assessed twice using functional magnetic resonance imaging (FMRI), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC. In phase 2, the investigators will perform a larger randomized clinical trial (RCT) (vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained FMRI changes.

NCT ID: NCT03838510 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Repeated-dose Behavioral Intervention to Reduce Opioid Overdose

REBOOT
Start date: February 2019
Phase: N/A
Study type: Interventional

REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.

NCT ID: NCT03837860 Not yet recruiting - Opioid Dependence Clinical Trials

Reducing the Abuse of Opioids in Drug Users

Start date: March 31, 2019
Phase: Early Phase 1
Study type: Interventional

The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly abused class of substances in the United States. Moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. In this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described. The study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.