Blended smartphone intervention for patients in opioid maintenance treatment in Iran: protocol for a randomized controlled trial.

BACKGROUND: The pattern of substance use in Iran is characterized by a high prevalence of opioid use and opioid use disorder (OUD). Although opioid maintenance therapy (OMT) has been introduced in Iran, approximately 50% of people with opioid use disorder remain unreached. Moreover, psychosocial treatment of OUD and common mental health symptoms during OMT is limited. Digital interventions have been shown to improve psychological distress, depression, anxiety, and post-traumatic stress disorder symptoms. In addition, providing psychoeducation and risk reduction counseling to prevent communicable diseases like HIV and infectious hepatitis is common via the Internet. However, despite these promising advances, no smartphone intervention in OMT has been investigated for the treatment of OUD and common comorbid mental health symptoms. OBJECTIVE: We examine the effectiveness of adding a blended smartphone intervention based on community reinforcement approach, motivational interviewing- and cognitive behavioral therapy compared to OMT as usual that aims to improve OMT outcomes and addresses common mental health symptoms in OMT patients in Iran. METHOD: Adults with opioid dependence entering 8 treatment centers in Tehran, Iran will be randomly assigned to receive either OMT plus a smartphone intervention or OMT as usual. The primary outcomes will be the percentage of negative urine tests for illicit, non-prescribed use of opioids (opium, heroin, tramadol) and treatment retention. Secondary outcomes will include the longest period of abstinence from the illicit, non-prescribed use of opioids (opium, heroin, and tramadol) confirmed by urine samples, changes in communicable disease risk-taking behaviors, changes in stress and common mental health symptoms, and client satisfaction. Data analysis will follow the intention-to-treat principle and employ (generalized) linear mixed models. DISCUSSION: This study will provide substantial knowledge for designing effective blended interventions for OUD. Moreover, it will investigate if treatment retention and OMT-related outcomes and common mental health symptoms can be improved by adding a smartphone intervention to OMT. TRIAL REGISTRATION: https://en.irct.ir/trial/53578 .

Population Size Estimation of People Who Use Illicit Drugs and Alcohol in Iran (2015-2016).

BACKGROUND: Estimating the number of people using illicit drugs and alcohol is necessary for informing health policy and programming. However, it is often challenging to reliably estimate the size of these marginalized populations through direct methods. In this study, we estimated the population size of these groups using the indirect Network Scale-Up (NSU) method in Iran from 2015 to 2016. METHODS: Using a self-administered questionnaire, we asked 15 124 individuals (54% men) about the number of people they know who used different types of drugs at least once in the past 12 months. Prevalence estimates were reported per 100 000 population. The uncertainty level (UL) was calculated using the bootstrap method. RESULTS: The average age of the respondents was 33 years old, and 35.1% of them were unmarried. The most common drugs and their prevalence were as follows: opium (2534 [95% UL: 2467-2598]), hashish (849 [95% UL: 811-886]), stimulants (methamphetamine, ecstasy pills, cocaine, and Ritalin) (842 [95% UL: 802-879]), heroin/crack (578 [95% UL: 550-607]), and drug injection (459 [95% UL: 438-484]). Additionally, we estimated the prevalence of alcohol use as 2797 (95% UL: 2731-2861). On average, substance use was 5.23 times more prevalent among men than women. Opium use was more prevalent among individuals aged >50 years old. Moreover, alcohol use was more prevalent among participants between 18 and 30 years old (5164 per 100 000 population). CONCLUSION: Although opium continues to be the most prevalent illicit drug in Iran, the patterns of illicit drug use are heterogeneous among different age groups, genders, and provinces. Age-gender specific and culturally appropriate interventions are warranted to meet the needs of people in different subgroups.

Factors influencing engagement and utilisation of opium tincture-assisted treatment for opioid use disorder: A qualitative study in Tehran, Iran.

INTRODUCTION: In response to a high burden of opioid use disorder (OUD), Iran established a network of opioid agonist treatment (OAT) centres beginning in 2002. To increase treatment diversity, particularly for patients who use opium as their drug of choice, opium tincture (OT)-assisted treatment was introduced to the network. This study aimed to explore factors influencing OT-assisted treatment selection for OUD in Tehran, Iran. METHODS: We conducted 54 in-depth interviews with patients with OUD (n = 33), family members of patients (n = 9) and drug treatment providers (n = 12). Participants were recruited from 12 drug treatment centres across Tehran, between September and November 2019. All interviews were audio-recorded, transcribed and coded in OpenCode 4.02 software and analysed using thematic analysis. RESULTS: Study participants more commonly reported individual-level factors as facilitators (e.g. to reduce harms associated with illicit opioid use, achieve recovery through a gradual dose reduction regimen combined with Congress 60 recovery program) and structural level factors (e.g. low adoption by OAT system and lack of familiarity of treatment providers) as barriers for utilisation of OT-assisted treatment regimens. OT was perceived to produce lower levels of physiological dependence than methadone, but the requirement for twice supervised dosing was restrictive. Low familial and community acceptance were also seen as barriers to access. DISCUSSION AND CONCLUSIONS: This research identified a range of perceived benefits for OT-assisted treatment ranging from harm reduction to an intermediate step to achieve recovery. However, several structural-, individual-, familial- and community-level barriers impede its availability and acceptability.

Opium tincture-assisted treatment for opioid use disorder: A systematic review.

BACKGROUND: Some countries have used opioid agonist medications other than methadone and buprenorphine as a strategy to increase treatment diversity. In Iran and other countries where opium use is common and culturally tolerated, opium tincture (OT) has gained growing popularity and been approved to treat opioid use disorder (OUD). Given the increasing interest in this intervention, we conducted a systematic review of the literature to evaluate the safety and efficacy of OT-assisted treatment for OUD. METHODS: We systematically searched international (MEDLINE, Embase, CINAHL, PsychInfo, Google Scholar, and clinicaltrials.gov) and Iranian (Scientific Information Database (SID), Iranmedex, IranDoc, digital library of Iran's Drug Control Headquarters and the Iranian Registry for Clinical Trials) databases on November 04, 2020 without any language or publication date limitations. Two reviewers screened the titles, abstracts, and full-text of the retrieved records to find clinical trials or observational studies that assessed the safety and efficacy of OT-assisted treatment for OUD. RESULTS: We screened 1301 records and included 21 unique studies on assisted withdrawal (n = 5), maintenance (n = 9), and gradual dose reduction (n = 7) treatment regimens. Most studies included men and people with opium use disorder. We found only six randomized controlled trials (RCT). Our results showed that OT-assisted treatment is associated with comparable outcomes with methadone treatment in both assisted withdrawal and maintenance treatment regimens. We also found promising results for using gradual dose reduction regimen of OT-assisted treatment from observational studies. The overall quality of scientific evidence was low due to the limited number RCT and high risk of bias in the included studies. CONCLUSIONS: The body of evidence supporting the safety and efficacy of OT-assisted treatment in assisted withdrawal, maintenance, and gradual dose reduction regimens is limited but somewhat promising, in particular among people with opium use disorder. Our review calls for higher-quality studies to investigate the comparative efficacy of these treatment methods with standard pharmacotherapies for OUD.

Population Size Estimation of Tramadol Misusers in Urban Population in Iran: Synthesis of Methods and Results.

BACKGROUND: Estimating the population who use drugs is essential for planning, monitoring, and evaluation of substance use prevention and treatment. This study aims to estimate the population who misuse tramadol in urban population in Iran. METHODS: We used the wisdom of the experts (WOTE) and network scale-up (NSU) methods to calculate the population of tramadol misusers in 10 provincial capitals of Iran, in 2016. The WOTE was conducted among pharmacists in drugstores and the personnel of traditional medicinal herbs stores. They guessed the best estimation of tramadol misusers population in their cities. The NSU method was conducted among the general population and participants were questioned about ever and daily, non-medical use of tramadol during last 12 months in their network. The median of the methods was used to calculate the proportion of the adult population (15-49 years old). FINDINGS: The population size of tramadol misusers in studied cities was 83300 [95% uncertainty limits (UL): 47960-256220]. This corresponded to 6.6 per 1000 (95% UL: 3.88-20.30) of the 15-49-year-old population. The projected number of tramadol misusers for all 31 provincial capitals was 118290 (95% UL: 68100-363130840) and 212440 (95% UL: 122310-653410) for all urban areas. NSU also estimated the number of people who misuse tramadol on daily basis. These numbers were 52000 (95% UL: 19940-176570) for studied cities, 73840 (95% UL: 28320-250740) for all 31 provincial capital cities, and 132610 (95% UL: 50860-450310) for all urban areas in Iran. CONCLUSION: This study presents information on high prevalence of tramadol misuse in urban population. We need national control measures and demand reduction programs to control tramadol misuse.

Lead poisoning outbreak among opium users in the Islamic Republic of Iran, 2016-2017.

OBJECTIVE: To describe an outbreak of lead poisoning among opium users in the Islamic Republic of Iran and estimate the number of affected people in the country. METHODS: We used data from the country's largest poison treatment centre to illustrate the epidemiology of an outbreak of lead poisoning in oral opium users. We describe the government's referral and treatment guidelines in response to the outbreak. Based on the number of individuals treated and previous studies on the prevalence of oral opium use we estimated the total number of people at risk of lead-contaminated opium nationwide. FINDINGS: In February 2016, we noticed a steep increase in the numbers of oral opium users referred to our poison treatment centre with abdominal pain, anaemia and constipation. Numbers peaked in June 2016 but the outbreak was ongoing in August 2017. The mean blood lead level in a sample of 80 patients was 140.3 µg/dL (standard deviation: 122.6). Analysis of an illegal opium sample showed 3.55 mg lead in 1 g opium. Treatment was exposure reduction with opioid substitutes and laxatives, or chelation therapy if indicated. Over 7 months, 4294 poison cases were seen at main referral hospitals in Tehran out of an estimated 31 914 oral opium users in the city. We estimate more than 260 000 out of 773 800 users nationwide remain untreated and at risk of poisoning. CONCLUSION: Lead-contaminated opium and heroin that has transited through the Iranian markets is a global risk and highlights a need for better monitoring of illegal drug supplies.

Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol.

BACKGROUND: In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. PATIENTS AND METHODS: This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. DISCUSSION: This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article.

Effectiveness of Mindfulness-Based Group Therapy Compared to the Usual Opioid Dependence Treatment.

OBJECTIVE: This study investigated the effectiveness of mindfulness-based group therapy (MBGT) compared to the usual opioid dependence treatment (TAU).Thirty outpatients meeting the DSM-IV-TR criteria for opioid dependence from Iranian National Center for Addiction Studies (INCAS) were randomly assigned into experimental (Mindfulness-Based Group Therapy) and control groups (the Usual Treatment).The experimental group undertook eight weeks of intervention, but the control group received the usual treatment according to the INCAS program. METHODS: The Five Factor Mindfulness Questionnaire (FFMQ) and the Addiction Sevier Index (ASI) were administered at pre-treatment and post-treatment assessment periods. Thirteen patients from the experimental group and 15 from the control group completed post-test assessments. RESULTS: The results of MANCOVA revealed an increase in mean scores in observing, describing, acting with awareness, non-judging, non-reacting, and decrease in mean scores of alcohol and opium in MBGT patient group. CONCLUSION: The effectiveness of MBGT, compared to the usual treatment, was discussed in this paper as a selective protocol in the health care setting for substance use disorders.

Outbreak of exogenous Cushing's syndrome due to unlicensed medications.

OBJECTIVE: Despite the widespread medical use of glucocorticoids, reports of factitious administration of these hormones have been uncommon. We herein report an outbreak of Cushing's syndrome in Tehran among the addicts using Tamgesic (a brand of Buprenorphine) to help them through the narcotic withdrawal stage, without knowledge of the glucocorticoid content of the black-market drug. DESIGN AND MEASUREMENTS: Case histories of 19 patients with a final diagnosis of iatrogenic Cushing's syndrome were reviewed. Liquid chromatography/mass spectrometry (LC-Mass) method was used to evaluate glucocorticoid existence in the brand. High performance liquid chromatography was used to determine plasma dexamethasone level. RESULTS: No buprenorphine was present in the vials. Each Tamgesic vial contained 0.4 mg of Dexamethasone disodium phosphate; Heroin was also found in them. The duration of injection abuse and the total dexamethasone intake was 4.5 (1-18) months and 2.6 (0.8-8) mg/day, respectively. Median plasma dexamethasone concentration was 5.8 nmol/l, with a range of 5-8.7. Physical findings of the cases were not different from those of the classic endogenous Cushing's syndrome but their serum cortisol and urinary free cortisol were suppressed. Severe life-threatening complications were demonstrated in five cases. CONCLUSION: Surreptitious use of steroids resulting in Cushing's syndrome may be more common in opium addicts; a high degree of suspicion is needed to uncover this disorder. Whenever facing a cushingoid appearance in addicts, the possibility of using black market drugs with corticosteroid contents should be kept in mind.