Implementing substance abuse group therapy clinical trials in real-world settings: challenges and strategies for participant recruitment and therapist training in the Women's Recovery Group Study.

BACKGROUND AND OBJECTIVES: Open-enrollment group therapy research is challenged by the participant recruitment necessary to ensure continuous group enrollment. We present successful strategies to overcome the following barriers during the Women's Recovery Group (WRG) two-site clinical trial (N = 158): maintenance of sample size and balanced gender randomization during continuous enrollment, maintenance of group attendance, and training and retention of therapists over the 24-month continuous group enrollment. METHODS: To increase recruitment, we targeted referral sources yielding the highest enrollment conversion at each site. Group sessions were consistently held regardless of group size. Therapists were trained in two teams allowing for coverage and uninterrupted treatment over 24 months. RESULTS: At both sites recruitment and enrollment increased with each successive quarter. Sample size and end date targets were met without disruptions in treatment. Group therapists reported high satisfaction with their training and treatment experiences. DISCUSSION AND CONCLUSIONS: These strategies supported targeted enrollment and study duration, stability of open-enrollment group therapy frame, and therapist retention and satisfaction. SCIENTIFIC SIGNIFICANCE: Applying these strategies can aid in providing evidence-based group therapy in both clinical and research settings.

Extended-release naltrexone (XR-NTX) attenuates brain responses to alcohol cues in alcohol-dependent volunteers: a bold FMRI study.

Oral naltrexone reduces heavy drinking, but is less consistent as an abstinence promoter, whereas once-monthly extended-release naltrexone (XR-NTX) also maintains abstinence. The present study sought to determine if alcohol cue reactivity is attenuated by XR-NTX. Twenty-eight detoxified alcohol-dependent adult male and female volunteers received a single i.m. injection of either XR-NTX or placebo under double-blind conditions. An fMRI/cue reactivity procedure was conducted immediately before and two weeks after injection. At baseline, alcohol-related visual and olfactory cues elicited significant increases in orbital and cingulate gyri, inferior frontal and middle frontal gyri. Subsequently, brain activation was significantly altered in XR-NTX-treated individuals. These affected brain regions are associated with the integration of emotion, cognition, reward, punishment, and learning/memory, suggesting that XR-NTX attenuates the salience of alcohol-related cues. Such an effect on brain function may interrupt the processes associated with "slips" and relapse, which may account for XR-NTX's ability to maintain abstinence.

Cognitive behavioral therapy and the nicotine transdermal patch for dual nicotine and cannabis dependence: a pilot study.

BACKGROUND AND OBJECTIVES: We assessed the feasibility of a new cognitive behavioral therapy (CBT) manual, plus transdermal patch nicotine replacement therapy (NRT), to treat co-occurring nicotine and cannabis dependence. METHOD: Seven of 12 (58.3%) adults with DSM-IV diagnoses of both nicotine and cannabis dependence completed 10 weeks of individual CBT and NRT. RESULTS: Participants smoked 12.6 ± 4.9 tobacco cigarettes per day at baseline, which was reduced to 2.1 ± 4.2 at the end of treatment (F[5] = 23.5, p < .0001). The reduction in cannabis use from 10.0 ± 5.3 inhalations per day at baseline to 8.0 ± 5.3 inhalations per day at 10 weeks was not significant (F[5] = 1.12, p = .37). There was a significant decrease from the mean baseline Fagerstrom Test for Nicotine Dependence scores at weeks 4, 6, 8, and 10 of treatment (F[4] = 19.8, p < .001) and mean Client Satisfaction Questionnaire scores were uniformly high (30.6 ± 1.9). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: A CBT plus NRT treatment program significantly reduced tobacco smoking but did not significantly reduce cannabis use in individuals with co-occurring nicotine and cannabis dependence. There was no compensatory increase in cannabis use following the reduction in tobacco smoking, suggesting that clinicians can safely pursue simultaneous treatment of co-occurring nicotine and cannabis dependence. The intervention was well-liked by the 7 of the 12 enrollees who completed the study.

Sex, age, and progression of drug use in adolescents admitted for substance use disorder treatment in the northeastern United States: comparison with a national survey.

BACKGROUND: National adolescent drug use surveys are distributed in United States schools. Survey results determine trends in drug use and inform research and prevention efforts; however, students who have dropped out of school or were truant the day of the survey are excluded. Examining drug trends in a high-risk population (adolescents admitted for drug treatment) may better characterize drug users and their use patterns. METHODS: The current study examined questionnaires completed by 939 adolescents admitted for substance abuse treatment between 1995 and 2010. RESULTS: Age of first use (ranging from 13.2 years for alcohol to 15.1 years for cocaine) was significantly younger for cigarettes, alcohol, and cannabis than for "harder" drugs such as cocaine and heroin, and adolescents increased their use of almost every substance (except inhalants) with increasing age. This was not true of national data. Additionally, in the national data, less than 1.5% of participants reported using any of the harder drugs more than 5 times, but in the McLean data, even for harder drugs, >10% of adolescents used >50 times. CONCLUSIONS: In the high-risk sample examined here, progression to harder drugs is accelerated and increases with age regardless of sex. These data underscore the importance of prevention and immediate treatment when adolescent substance use is identified.

Adolescent substance use and unplanned pregnancy: strategies for risk reduction.

Substance use among adolescents increases the risk of unplanned pregnancies, which then increases the risk of fetal exposure to addictive, teratogenic substances. Specific interventions are necessary to target pregnancy planning and contraception among reproductive-age substance users. Screening for substance use using the CRAFFT is recommended in all health care settings treating adolescent patients. Screening for tobacco and nicotine use is also recommended along with the provision of smoking cessation interventions. Using motivational interviewing style and strategies is recommended to engage adolescents in discussions related to reducing substance use, risky sexual behavior, and probability of unplanned pregnancy or late-detection pregnancy.

Group therapy for women with substance use disorders: results from the Women's Recovery Group Study.

BACKGROUND: This Stage II trial builds on a Stage I trial comparing the single-gender Women's Recovery Group (WRG) to mixed-gender Group Drug Counseling (GDC) that demonstrated preliminary support for the WRG in treating women with substance use disorders. The Stage II trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance of abuse and co-occurring psychiatric disorders, and (2) demonstrate the feasibility of implementing WRG in an open-enrollment group format at two sites. METHOD: In this randomized clinical trial, participants were included if they were substance dependent and had used substances within the past 60 days (n=158). Women were randomized to WRG (n=52) or GDC (n=48); men were assigned to GDC (n=58). Substance use outcomes were assessed at months 1-6 and 9. RESULTS: Women in both the WRG and GDC had reductions in mean number of substance use days during treatment (12.7 vs 13.7 day reductions for WRG and GDC, respectively) and 6 months post-treatment (10.3 vs 12.7 day reductions); however, there were no significant differences between groups. CONCLUSIONS: The WRG demonstrated comparable effectiveness to standard mixed-gender treatment (i.e., GDC) and is feasibly delivered in an open-group format typical of community treatment. It provides a manual-based group therapy with women-focused content that can be implemented in a variety of clinical settings for women who are heterogeneous with respect to their substance of abuse, other co-occurring psychiatric disorders, and life-stage.

A standardized kudzu extract (NPI-031) reduces alcohol consumption in nontreatment-seeking male heavy drinkers.

OBJECTIVE: We previously demonstrated that short-term treatment with a standardized kudzu extract (NPI-031) reduced alcohol drinking by men and women in a natural setting. The present study was conducted in nontreatment-seeking heavy drinkers to assess the safety and efficacy of 4 weeks of kudzu extract in an outpatient setting. METHOD: This randomized between-subject, double-blind, placebo-controlled study involved 2 weeks of baseline, 4 weeks of treatment, and 2 weeks of follow-up. Seventeen men (21-33 years) who reported drinking 27.6 ± 6.5 drinks/week with a diagnosis of alcohol abuse/dependence took either kudzu extract (250 mg isoflavones, t.i.d.) or matched placebo on a daily basis. They reported alcohol consumption and desire to use alcohol using a wrist actigraphy device; twice weekly laboratory visits were scheduled to monitor medication adherence and adverse events. RESULTS: Medication adherence was excellent and there were no adverse events and changes in vital signs, blood chemistry, and renal or liver function. There was no effect on alcohol craving, but kudzu extract significantly reduced the number of drinks consumed each week by 34-57 %, reduced the number of heavy drinking days, and significantly increased the percent of days abstinent and the number of consecutive days of abstinence. CONCLUSIONS: A standardized formulation of kudzu extract produced minimal side effects, was well-tolerated, and resulted in a modest reduction in alcohol consumption in young nontreatment-seeking heavy drinkers. Additional studies using treatment-seeking alcohol-dependent persons will be necessary to determine the usefulness of this herbal preparation in reducing alcohol use in other populations.

Eight weeks of citicoline treatment does not perturb sleep/wake cycles in cocaine-dependent adults.

BACKGROUND: Citicoline (cytidine-5'-diphosphate) is a mononucleotide composed of ribose, cytosine, pyrophosphate, and choline, and is involved in the biosynthesis of the structural phosopholipids of cell membranes. Treatment with citicoline, improves memory in patients with dementia, and reduces damage to the brain after traumatic brain injury or stroke. Recent research has been conducted to assess whether citicoline is an effective treatment for cocaine dependence. In cocaine-dependent individuals, withdrawal from cocaine is associated with disturbed sleep, which may contribute to the high rate of relapse to cocaine use. Therefore, it is important to know the impact of citicoline on the sleep/wake cycle in these individuals in order to rate its overall efficacy. METHOD: In this double-blind, placebo-controlled trial, the effects of citicoline treatment on the sleep/wake cycles of cocaine dependent participants were assessed. The results of the current study are reported as part of a larger study, consisting of an eight-week treatment period to assess the efficacy of longer-term treatment with citicoline at decreasing cocaine consumption in cocaine-dependent polydrug using participants. RESULTS: In this non-abstinent, cocaine-dependent population, citicoline had no effect on any of the sleep parameters measured including sleep efficiency, sleep latency, total sleep time, number of waking episodes, time awake per episode, amount of time in bed spent moving, number of sleep episodes, time asleep per episode, and amount of time in bed spent immobile. CONCLUSIONS: These data suggest that eight weeks of citicoline administration does not disturb sleep/wake cycles of cocaine-dependent individuals.

Cue reactivity in cannabis-dependent adolescents.

The authors measured event-related potentials with a craving manipulation to investigate the neural correlates of drug cue reactivity in 13 adolescents who are cannabis dependent (CD; ages 14-17). The P300 responses to marijuana (MJ) pictures (MJ-P300) and control pictures (C-P300) were assessed after handling neutral objects and again after handling MJ paraphernalia (MJP). Self-reported drug craving and heart rates also were measured. MJ-P300 were larger than C-P300 (p < .001), and both the MJ-P300 and craving increased significantly after handling MJP (p = .002 and p = .003, respectively), with no association between the magnitude of craving and MJ-P300. Heart rates were not affected by handling MJP. The results showed that adolescents who are CD have an attentional bias to MJ stimuli that increases after handling marijuana paraphernalia. Generally, the results are consistent with what has been reported for adult heavy chronic cannabis smokers, although there were some differences that require further investigation.

Effects of daily treatment with citicoline: a double-blind, placebo-controlled study in cocaine-dependent volunteers.

UNLABELLED: Many pharmacotherapies for treating cocaine dependence are aimed at reducing drug effects, alleviating craving, and preventing relapse. We demonstrated previously that citicoline, a compound used to repair neuronal damage in stroke and brain injury, is safe in cocaine-abusing volunteers. OBJECTIVES: This study assessed the effectiveness of an 8-week citicoline treatment period and 4-week follow-up in cocaine-dependent individuals. METHODS: Twenty-nine healthy nontreatment-seeking, cocaine-dependent male and female volunteers were randomized in this double-blind, placebo-controlled study, 18 of whom completed the treatment period of the study. Participants took citicoline (500 mg twice daily) or matched placebo each day and recorded the measures of craving and drug use. Participants visited the laboratory twice a week for urine screens and to attend weekly group therapy sessions. RESULTS: Citicoline had no effect on cocaine craving or total use. CONCLUSIONS: Although the current preliminary results from this small trial suggest that citicoline is not an effective treatment for heavy cocaine users, further investigation on efficacy citicoline as a treatment for substance dependence in other settings may be warranted.

What do adolescents exposed to Alcoholics Anonymous think about 12-step groups?

OBJECTIVES: Referral to Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) is a common continuing care recommendation. Evidence suggests some youth benefit, yet, despite referrals, youth participation is low. Little is known about adolescents' experiences of AA/NA. Greater knowledge would inform and help tailor aftercare recommendations. METHOD: Two clinical samples of youth (N = 74 and N= 377) were asked about their perceptions of, and experiences with, AA/NA with responses categorized by content into domains assessed for face validity and reliability. RESULTS: The aspects of AA/NA youth liked best were general group dynamic processes related to universality, support, and instillation of hope. The most common reason for discontinuing was boredom/lack of fit. CONCLUSIONS: General group-therapeutic, and not 12-step-specific, factors are most valued by youth during early stages of recovery and/or degree of AA/NA exposure. Many youth discontinue due to a perceived lack of fit, suggesting a mismatch between some youth and aspects of AA/NA.