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CTN Protocol Summaries December 8, 2004

  • Suboxone (Buprenorphine/Naloxone) Taper: A Comparison of Two Schedules
    (CTN 0003)
  • Buprenorphine/Naloxone-Facilitated Rehabilitation for Heroin Addicted Adolescents/Young Adults
    (CTN 0010)
  • Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome in Pregnant Substance Users
    (CTN 0013)
  • Brief Strategic Family Therapy (BSFT) For Adolescent Drug Abusers
    (CTN-0014)
  • Women’s Treatment for Trauma and Substance Use Disorders
    (CTN 0015)
  • HIV and HCV Intervention In Drug Treatment Settings
    (CTN 0017)
  • HIV/STD Safer Sex Skills Groups For Men In Methadone Maintenance Or Drug-Free Outpatient Treatment Programs
    (CTN-0018)
  • HIV/STD Safer Sex Skills Groups For Women In Methadone Maintenance Or Drug-Free Outpatient Treatment Programs
    (CTN-0019)
  • Job-Seekers Training for Patients with Drug Dependence
    (CTN 0020)
  • Motivational Enhancement Treatment To Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse
    (CTN 0021)

 

Suboxone (Buprenorphine/Naloxone) Taper: A Comparison of Two Schedules
(CTN 0003)
to the top
For decades clinicians have been frustrated by the inability to successfully detoxify opiate addicted patients because opiate-based detoxification, one of the most effective means to achieving that goal, has been unavailable outside the very restrictive confines of narcotic treatment programs (NTPs). A new medication, Buprenorphine, shows promise as an effective aid for opiate detoxification. However, little data have been generated for the shorter-term use of Buprenorphine/Naloxone for this indication. This protocol will compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.

Buprenorphine/Naloxone-Facilitated Rehabilitation for Heroin Addicted Adolescents/Young Adults (CTN 0010) to the top
The use of heroin by American adolescents is at its highest level since the 1960s. However, the treatment of young heroin users has not been particularly effective, and some treatment providers are reluctant to use the medications they reserve for their older patients, especially for long-term opioid maintenance. This study compares two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and “treatment as usual”— a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy. The researchers believe the use of a 3-month stabilization with buprenorphine/naloxone in combination with psychosocial therapy will more effectively reduce heroin use, help these young people comply with their treatment, and improve their overall adjustment than brief detoxification with buprenorphine.

Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome in Pregnant Substance Users (CTN 0013) to the top
About 5% of women use illicit substances during pregnancy, and approximately 22% of these also report using tobacco or alcohol. A number of treatment programs have started to offer treatment specifically designed for pregnant substance abusers. While these programs have shown some success, it is still difficult to keep these women in treatment. Brief motivational sessions have been found to improve treatment engagement and outcomes in both alcohol and drug using women. This study compares one such treatment intervention, Motivational Enhancement Therapy (MET), with standard treatment. The three individual MET sessions focus on developing rapport, exploration of perceived pros and cons of using substances, reviewing the participant feedback on the consequences of substance use and the status of her pregnancy, and developing a change plan or strengthening the commitment to change. Patients assigned to standard treatment receive the treatment normally given in that clinic; this will include at least three individual sessions that are also designed to help them overcome alcohol and drug use.

Brief Strategic Family Therapy (BSFT) For Adolescent Drug Abusers (CTN-0014) to the top
Adolescent drug abuse continues to be one of the most pressing public health issues in the United States--our nation’s teenagers continue to use illicit drugs at a worrisome rate. Broad reviews of the treatment outcome literature indicate that family interventions in general, and BSFT in particular, are effective with drug using youth. This study is designed to compare BSFT to treatment as usual (TAU). The researchers believe that BSFT will be much more effective than TAU in reducing adolescent drug use. They will also examine which of these treatment approaches does a better job of engaging adolescents and family members in treatment, decreasing problem behaviors, decreasing sexually risky behaviors, increasing pro-social activities (e.g., school, work), and improving the functioning of the family.

Women’s Treatment for Trauma and Substance Use Disorders (CTN 0015) to the top
Posttraumatic stress disorder (PTSD) is common among drug users, particularly among women. Those who suffer from both of these conditions also struggle more with both conditions and have a more difficult time meeting their treatment goals. Estimates also suggest that as many as 80% of women seeking treatment for drug abuse report lifetime histories of sexual and/or physical assault. These facts highlight the importance of finding effective treatments for this high-risk population. Early studies show Seeking Safety, a substance abuse treatment designed specifically for women with trauma, to be an option with great potential for this population. This study compares the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women’s Health Education to standard substance abuse treatment. The researchers will be looking at the effect of these treatment options on both substance use and the severity of the posttraumatic stress disorder. In addition, they will look at the results in relation to demographic and individual characteristics of those in the study.

HIV and HCV Intervention In Drug Treatment Settings (CTN 0017) to the top
The connection between AIDS and drug injection is well established. Through June 2000, injection drug users accounted for more than a third of all cases reported among persons aged 13 or older to the Centers for Disease Control and Prevention. Hepatitis C virus (HCV), transmitted primarily through sharing drug preparation and injection equipment, is also a major public health concern. Sixty percent of HCV transmission is related to injection drug use and as many as 50-95% of injection drug users are infected with HCV. This study tests two strategies to reduce the risk of contracting HIV or HCV by reducing risk behaviors in patients undergoing drug detoxification. The first includes pre-test counseling, testing, post-test counseling, and the provision of HIV/HCV results. The second strategy, called therapeutic alliance, provides clients with information to guide them through the process of role induction and aims to facilitate transition to continuing care for drug treatment. Both will be compared to standard care in drug detoxification settings.

HIV/STD Safer Sex Skills Groups For Men In Methadone Maintenance Or Drug-Free Outpatient Treatment Programs (CTN-0018) to the top
Drug treatment, itself, can have a powerful positive effect on HIV drug use risk behavior, especially needle use behaviors. However, sexual risk behavior has received less attention and has been slower to change. Research suggests, however, that men and women are less likely to engage in risky sex behavior with a skill-based HIV risk reduction intervention, peer group discussion, and the use of separate sex sessions. This study evaluates a five-session HIV/AIDS group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education. The researchers hypothesize that men in the gender-specific therapy group will report less risky sexual behavior than men in standard therapy. They are also expected to have a more positive attitude of condom use, be more likely to have condoms, be more likely to have taken condoms from clinic supplies, report less drug use in combination with sex, and hold more egalitarian attitude toward women.

HIV/STD Safer Sex Skills Groups For Women In Methadone Maintenance Or Drug-Free Outpatient Treatment Programs (CTN-0019) to the top
Women in drug-using communities are one of the fastest growing groups of people with AIDS in the U.S. Female drug users, even if they are in drug treatment, are at especially high risk for heterosexual transmission of HIV. First, they are often in primary sexual relationships with male drug users. Second, like their male peers, despite treatment, some continue to use drugs. Under the influence of drugs, especially cocaine or crack, they are more likely to engage in unprotected sex. It has been shown that drug abuse treatment can reduce activities related to drug use that increase the risk of getting or transmitting HIV. These behaviors have received less attention, however, than those directly related to drug use. This study looks at a program for women in drug abuse treatment designed to build safer sexual skills and reduce unprotected sexual risk behavior. The program includes five sessions of group treatment that focus on assessing HIV risk, HIV safer sex problem solving, condom use, negotiation skills, and assertiveness training. This program will be compared to one session of HIV/STD education, which is typically provided as standard in drug treatment clinics.

Job-Seekers Training for Patients with Drug Dependence (CTN 0020) to the top
Drug abuse clients who are employed typically do better in their treatment than those who are unemployed. In addition, unemployment is a chronic problem in drug-dependent people. Despite the high rates of unemployment in this population, community treatment programs often don’t have the resources to provide vocational services. This study will examine the effectiveness of a 12-hour basic job-training program designed to give patients the skills they need to find and secure a job and set vocational goals and methods for locating employment. The intervention to be evaluated is modeled after the Job Seekers’ Workshop, which was manualized and has been tested in trials.

Motivational Enhancement Treatment To Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse (CTN 0021) to the top
Because Spanish-speaking drug users are often not included in studies of drug abuse treatment, little is known about what works with this population. On the other hand, there is research that shows that this minority group carries attitudes and beliefs about substance abuse that may be barriers to participation in substance abuse treatment. A few studies do indicate, however, that efforts to motivate substance-abusing Hispanics can be effective in bringing them into treatment. One such intervention, Motivational Enhancement Therapy (MET), is a promising intervention that may increase Hispanic clients’ commitment to change and reduce their resistance to entering treatment. This study compares a three-session Spanish version of MET to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment. The researchers are also going to look at the characteristics of the participants to see if there is a particular type of patient that is suited for MET and a number of other factors.

 

 

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12/8/2004 mw

 

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