It is feasible to recruit and retain methamphetamine-dependent gay men in a pharmacologic drug-treatment programme, US investigators report in the April 24th edition of AIDS.
The men participating in the study reduced their risky sexual behaviour, and methamphetamine use declined; however, adherence to the study medication was poor.
“We demonstrated that it is feasible to enrol and retain actively using, high-risk, meth-dependent MSM [men who have sex with men] in a pharmacologic intervention trial…with excellent rates of participation in study visits, procedures, and follow-up evaluations,” comment the investigators.
Methamphetamine ('meth') is a highly addictive and potentially destructive drug. It is estimated that 0.5% of the US population use the drug, but much higher rates of usage have been observed in gay men. Some research suggests that use of the drug is contributing to the ongoing transmission of HIV in this population.
Pharmacologic therapies can help treat addiction to other illegal and legal drugs, such as heroin, nicotine and alcohol. Bupropion is currently being investigated as a possible drug therapy for meth dependence.
Given the high rates of meth use by gay men and the drug’s role in the transmission of HIV, investigators wished to see if it was possible to recruit and retain gay men who used the drug in a bupropion treatment programme.
A total of 30 gay men were recruited to the prospective, double-blind, randomised study between 2006 and 2007.
Twenty of the men were randomised to receive bupropion, the other ten men receiving a placebo.
The study lasted twelve weeks. Using MEMS caps (which record the opening of medicine containers) and patient recall, adherence to the study medication was assessed. Attendance at monthly study follow-up appointments, and weekly risk-reduction counselling was also recorded.
A total of 27 men (90%) completed the trial, with no differences between the number retained in the treatment and placebo arms.
Overall, 89% of the monthly follow-up appointments were kept, as were 81% of the weekly risk-reduction counselling sessions. There was no difference in attendance between the two arms of the study.
Adherence measured by the MEMS caps was 60%, and self-reported adherence was somewhat higher at 81%. Once again, no significant differences were seen between those who received bupropion and those who were given the placebo. Common reasons for non-adherence included forgetfulness (18%) and change in routine (16%). However, being “high on meth” accounted for 9% of poor adherence.
“Our modest adherence rates suggest that upcoming studies of pharmacologic interventions for meth dependence should be accompanied by adherence support measures that address the complex needs of this population,” recommend the researchers.
In both arms of the study, the mean number of reported sex partners fell, as did the use of meth during sex, and reported unprotected anal sex.
“These findings indicate that meth-dependent MSM engaged in pharmacologic interventions with concomitant substance use couseling can reduce their sexual risk behaviors,” write the investigators. However, one man tested HIV-positive during the study, at which time he was also diagnosed with rectal gonorrhoea.
At the end of the study, 96% of participants were satisfied or very satisfied with their participation and 93% said that they would be willing to participate in similar research in the future.
On entry to the study, 65% of individuals in the bupropion arm had meth detected in their urine, as did 90% of men in the placebo arm. By the end of the study this had fallen to 56% and 74% respectively.
No serious side-effects were observed.
The investigators were encouraged by these results, and conclude: “We must intensify our efforts to identify potential pharmacologic therapies for meth dependence, and to enrol high-risk populations, both to reduce meth-related morbidity and to further prevent HIV acquisition and transmission.”
Das M et al. Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men. AIDS 24: 991-1000, 2010.