Breakingtheice: A protocol for a randomised controlled trial of an internet-based intervention addressing amphetamine-type stimulant use

Amphetamine-type stimulants (ATS) include an array of psychoactive substances, the most commonly used illicit ATS being methamphetamine, amphetamine and ecstasy (3,4-Methylenedioxymethamphetamine) [1, 2]. There are now an estimated 35 million ATS users worldwide compared with combined total of 29 million opioid and cocaine consumers [3, 4]. The age of initiation of ATS is typically in the mid-late teens, with levels of use often peaking in early adulthood. In Australia, the lifetime prevalence of use is highest among those aged 20-29 years (ecstasy 25%, meth/amphetamine 15%), with the respective 12-month figures being 10% and 6% among the same age group [5].

While the bulk of ATS use is recreational in nature, this population includes a sizable proportion of people who become dependent and experience chronic debilitating health problems as a result of their use of ATS [6]. Major health concerns include paranoia, aggression, increased risk of stroke and cardiovascular pathology [7]. Dependence on ATS, like dependence on any drug, is typically associated with a reduction in quality of life, premature mortality and elevated levels of crime [8]. This is particularly the case with the use of more potent ATS, such as crystalline methamphetamine, and with more efficient routes of administration (e.g., smoking or injecting) [9]. Reducing the impact of ATS use requires the simultaneous development of effective management strategies and methods to improve the uptake and accessibility of treatments for this population. The spectrum of ATS use will also need to be considered, from irregular use through to stimulant use disorders (abuse, dependence) [10].

Despite the widespread use of ATS, a systematic review concluded that, to date, there are insufficient data to support the use of pharmacotherapies such as fluoxetine, amlodipine, imipramine and desipramine in the treatment of amphetamine abuse and dependence [11]. However, research continues to assess other potential agents in the treatment of stimulant abuse [12, 13]. A review of psychosocial treatments for methamphetamine dependence reported that the intensive application of psychological interventions (e.g., contingency management, cognitive behavior therapy (CBT), motivational interviewing) can result in a moderate reduction in stimulant use [14]. Brief cognitive behavioral interventions, of up to four sessions duration, have also been shown in previous research to be associated with significant reductions in amphetamine use and significantly greater likelihood of abstinence than controls [15]. However, these types of structured psychological interventions are not widely implemented in community-based treatments for drug use, and ATS users seeking help from traditional drug and alcohol services frequently report their needs are not being met [10]. For example, among a sample of methamphetamine users in Queensland, Australia, the majority felt that more information about methamphetamine use should be available and more accessible outside treatment services and business hours [16]. In particular, respondents reported that needle and syringe programs, methadone maintenance programs and outpatient counseling should not be co-located, as doing so is viewed as a key barrier to treatment access. The need to develop appropriate, novel treatments that are well accepted by ATS communities is clear, including options for accessing treatments outside mainstream specialist treatment services [17].

Given that psychological treatments can reduce stimulant use [15, 18], there is the potential to develop internet-based treatments for ATS users, with many internet-based CBT treatment packages currently accessible via the world wide web [19]. The critical advantage offered by web-based interventions for mental health and substance use problems is that they have the potential to greatly reduce key barriers to obtaining treatment, in particular, stigma (given the anonymous access), cost (with free treatment), reach (potentially worldwide coverage and 24 hour access), especially for those living outside of metropolitan areas [20, 21]. This is important in the context of ATS use, not only because of the number of people potentially requiring treatment but because surveys show that stimulant users are reluctant to seek treatment from existing drug treatment services as most are tailored toward clients with opiate or alcohol problems [1, 22]. Furthermore, for those with addictive disorders, access to treatment ‘24/7’ may be a particularly important benefit of internet services, allowing the potential to capitalize on times of high motivation to change behavior and access to resources when the risk of relapse is high.

Internet-based interventions have already been demonstrated as effective for the treatment of depression and a range of anxiety disorders [23]. With respect to substance use, web-interventions have been effective in reducing problematic use of alcohol in young adults [24] and in reducing cannabis use via school-based interventions that involve on-line materials [25]. Brief internet interventions have been shown to reduce drug use and ‘high-risk’ behavior in human immunodeficiency virus (HIV) positive drug users [26] and a computerized intervention using combined CBT and motivational interviewing (MI) has been reported to reduce cannabis and alcohol use among those with co-morbid major depression [27]. However, the current authors are not aware of any evaluated internet based interventions for the use of ATS.

The objective of the study was to adapt existing face-to-face psychological approaches (i.e., CBT and MI) for delivery via the internet to reduce the use of ATS and associated problems plus improve motivation to reduce ATS use, with assessment of effectiveness at 3 and 6 months post-intervention.

To the best of our knowledge, this is the first internet intervention developed specifically for users of ATS. Outcomes will be evaluated against critical measures, including changes in the use of ATS, improved mental wellbeing and quality of life. The randomized design and 6 month follow-up will allow firm conclusions to be drawn and, if successful, will justify the dissemination of the site into an effectiveness trial, i.e. under ‘real world’ conditions, and with evaluation to 12 months. There is already evidence that it is feasible and effective to transition internet interventions for substance abuse from randomized trials into open access sites to provide resources to the general community, at least in the case of cessation of smoking [45].

There are a number of ethical issues that are common to internet interventions. Firstly, for ethical reasons the minimum age for participants is 18 years. Although participants are explicitly asked to confirm that they are aged 18 years or older, it will not be possible to ensure that all participants are adults [46]. Secondly, since participants are recruited via an online mechanism, the extent that consent is ‘informed’ is not as transparent compared with face-to-face recruitment. However, the consent process includes multiple tick boxes covering critical issues and provides direct contact details of the chief investigator, as recommended [47]. Third, it is not possible to gauge if participants have become distressed by the content or activities of the intervention and provide clinical support. Therefore, the information sheet and resources in the trial web-site contain contact details for relevant agencies. Fourth, the study uses a waitlist control rather than an ‘attention control’, which means that exposure to the experimental setting could account for any changes observed, rather than the content of the modules.

It has been suggested that internet interventions incur a greater level of attrition than face-to-face interventions which threatens their internal validity [48]. The study has been designed to be ‘front-loaded’ with screening and baseline questionnaires applied before randomization and entry into the study; this may encourage early drop out by those with low motivation [48], but may limit subsequent generalization to more motivated participants. The use of MMRM analysis maximizes the use of available data collected during the study to minimize biases associated with attrition. A particular concern for internet interventions in the substance use domain is that of self-report of drug use without the potential to use biochemical verification (i.e. urine samples) as often used in face-to-face intervention trials. Nevertheless, there are data to support the reliability and validity of self-reported illicit drug use: indeed self-reports can reveal a greater extent of drug use than biochemical screening, with most illicit drugs only detectable for a short period [49].

If the intervention is effective, it will offer advantages over conventional, face-to-face interventions in that internet interventions can provide treatment virtually nationwide. In Australia, 80% of the population already has access to the internet at home with further access provided by public facilities such as libraries [50]. There is also the potential for access to the site by an increasing proportion of the population of the world. Further, the anonymous nature of the intervention may reach participants who are reluctant to engage with traditional drug treatment services due to fear of stigmatization or the belief that the services offered are not appropriate for those with ATS related problems rather than alcohol or opioid problems.

Recruitment is planned to commence in mid-2012