A pilot randomized controlled trial of dialectical behavior therapy (DBT) for reducing craving and achieving cessation in patients with marijuana use disorder: feasibility, acceptability, and appropriateness

Abstract Objective To conduct a pilot RCT investigating the feasibility, acceptability, and preliminary efficacy of dialectical behavioral therapy (DBT) for marijuana cessation and craving reduction. Methods Sixty-one patients with marijuana use disorder diagnoses were randomly assigned to a DBT group or a control group (psycho-education). Patients completed measures at pre-intervention, post-intervention, and at two-month follow-up. The Marijuana Craving Questionnaire (MCQ) and marijuana urine test kits were used to assess craving and abstinence respectively. Results The feasibility of DBT was significantly higher than control group feasibility. In the DBT 29/30 participants completed all sessions (96% retention) and 24/31 control group participants completed all sessions (77% retention) (χ2 = 4.95, p = 0.02). Moreover, 29/30 (96%) participants in the DBT group completed the two-month follow-up and 20/31 (64.5%) control group members completed the two-month follow-up (χ2 = 9.97, p = 0.002). The results showed that patients in the DBT group had significantly higher intervention acceptability rates (16.57 vs. 9.6) than those in the control group. This pattern was repeated for appropriateness rates (p < 0.05). The overall results for craving showed that there was no significant difference between the groups (F = 3.52, p > 0.05), although DBT showed a significant reduction in the “emotionality” subscale compared to the control group (F = 19.94, p < 0.05). To analyze cessation rates, DBT was compared to the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%) and the results confirmed higher effectiveness in the DBT group for cessation (p < 0.05). Furthermore, among those who had lapsed, participants in the DBT group had fewer consumption days than those in the control group (p < 0.05). Conclusions DBT showed feasibility, acceptability, and promising efficacy in terms of the marijuana cessation rate. Clinical trial registration Thailand Registry of Clinical Trials, TCTR20200319007.


Introduction
Marijuana is the most prevalent substance among those reported to be a significant problem among people seeking treatment for substance abuse. 1 According to WHO reports, more than 140 million people consume marijuana every year. 2

With regard
to Iran, recent evidence shows that more than 5% of people consume marijuana every year, predominantly young males. However, in view of the harsh marijuana prohibition policy of the Iranian government, most clinicians estimate that these rates have been hugely underestimated. 3 Marijuana, as an illegal drug, is associated with significant physical, psychological, and social consequences. 4 Studies have shown that regular and heavy marijuana use patterns correlate with increased risk of mood disorders, anxiety, and psychotic episodes and although causality has not been demonstrated, these patterns can increase the course of mental health problems. 5 Also, several medical problems such as respiratory system deficits, stroke, myocardial infarction, and digestive tract cancers are associated with marijuana use patterns, especially among those with marijuana use disorder (MUD). 6,7 Approximately one in three marijuana users meet the criteria for MUD based on the DSM-5, and this proportion is rising. 8 One of the most important psychological problems in substance use disorder treatment is craving. Craving is a factor identified as the root cause of relapses and treatment failures. 9,10 MUD patients report visual, tactile, and olfactory cues related to craving and compulsivity sensations. 11 Based on these results, clinicians have tried to treat patients with marijuana use disorder.
To date, the Food and Drug Administration (FDA) in the United States has not approved any psychopharmacotherapy for MUD, and therefore psycho-social interventions have received particular attention. 12 The most widely used psychological treatment in the substance use disorder (SUD) context is cognitivebehavioral therapy (CBT). 13 Results showed that CBT is somewhat effective for SUD, but that most patients with MUD do not achieve cessation and are not motivated to continue skills training during followup. Relapse rates therefore remain a considerable limitation of treatment. 10 Overall, in the context of SUD, DBT teaches emotion regulation skills to decrease engagement in pathological emotion regulation strategies. It also intervenes in low quality of life situations, reduces drug-seeking behavior, and helps patients function adaptively by accepting unpleasant emotions such as craving. 9,10,14 Research literature shows the efficacy and effectiveness of DBT in various comorbid problems and diseases such as suicide, 16 forensic psychiatric patients, 17 and irritable bowel syndrome. 18 Nevertheless, studies have reported contradictory results for the effectiveness of implementing DBT in various SUD populations. 19,20 Furthermore, the literature has recommended using larger samples, clearer instruments to measure outcome variables, and specific and integrated protocols. 21 Additionally, according to our investigations, no

Trial design
This study was designed as a controlled randomized clinical trial, including pretest, post-test, and two-month follow-up phases.

Sample size
Since the sampling method comprises snowball sampling and strict eligibility criteria were applied, on the basis of data from similar studies 10 it was determined that at least 20 participants were needed in each group.
However, in view of the predicted retention rates, we selected 30 patients for each group.

Selection criteria
The inclusion criteria were as follows: 1) diagnosis of marijuana use disorder; 2) age 18 years or over; 3) no current or past history of major psychiatric disorders; 4) no other concurrent SUD treatment; and 5) willingness to attend intervention sessions, complete surveys, and take tests (questionnaires and urine test kits).
Exclusion criteria were as follows: 1) unwillingness to participate; 2) not participating in intervention sessions for more than two weeks; 3) starting secondary psychotherapy; and 4) consuming methamphetamine, amphetamine, cannabis, methadone, benzodiazepines, or morphine during the research stages.

Participants, procedures, and randomization
Since there are no cannabis use disorder treatment centers in Iran, there is no specific place to select patients. Furthermore, patients at drug treatment centers are referred for treatment of other substance use disorders and comorbidity of drug use is one of the exclusion criteria for this study, since it could lead to misleading results. Therefore, the relatives and acquaintances of those who had been referred to the drug treatment center were interviewed. From These patients were randomly assigned to each group using a random number

Marijuana smoking
A self-report scale was designed for patients who

Craving
The Marijuana Craving Questionnaire (MCQ) shortform is a 12-item self-report questionnaire with ten items for subjective assessment of cannabis craving.
The scale covers 4 factors: compulsivity, emotionality, expectancy, and purposefulness. According to how patients were thinking or feeling ''right now,'' they placed checkmarks on the questionnaire to endorse responses ranging from 1 or strongly disagree to 7 or strongly agree. Results showed that this questionnaire's internal consistency is adequate (α = 0.90). The measure was administered following a 12-hour deprivation period.
The typical onset of marijuana craving and withdrawal symptoms is observed within approximately one day of cessation and so the current paper's questionnaire scores can be conceptualized as an index of the propensity to experience marijuana craving following deprivation. 22 In Iranian MUD patients, the MCQ had internal consistency of α = 0.87. Details of the MCQ's psychometrics properties will be published as a separate study as soon as possible.

Acceptability
The Acceptability of Intervention Measure (AIM) was employed to measure the acceptability of interventions. Based on the treatment manual, modules were rated for adherence level as either adequate or not adequate. The majority (83%) were judged to have been conducted adequately.

Statistical method
Demographic information was gathered and reported as frequencies, means, and standard deviations and repeated measures ANOVA and chi-square tests were conducted for the outcomes using SPSS software, version 26.

Ethical considerations
Written informed consent was obtained from all participants before initiation of the research. The tools used in this study were all filled-out anonymously, and an ID code was used to maintain the confidentiality of personal information (Ir.kums.rce.1398.1203). At the end of the research process, dialectical behavior therapy was also provided to the control group. This study is registered with the Thailand Registry of Clinical Trials (TCTR20200319007).

Feasibility
In the psycho-education group, 24/31 participants  Teach two clusters of mindfulness skills. The first includes viewing, participation, and description. The second includes a non-judgmental stance and inclusive self-consciousness.

3rd session
Summarize the mindfulness sessions -definition of addiction, standard therapies of addiction, introduction to and teaching of dialectical avoidance technique. Review the positive and negative aspects of abstinence. Explanation and investigation of relapse and its causes. Explaining the skill of the pure mind, the addicted mind, the types of behaviors related to the pure mentality and the addicted mentality, and preparing a list of supporters.

4th-5th sessions (Distress tolerance)
Teaching distraction strategies with five skills include activities, comparisons, emotions, thoughts, and enjoyment. Through enjoyable activities, focusing on work or other topics, counting, leaving the situation, paying attention to daily tasks, distracting from thoughts, and self-harm behaviors -teaching and training self-soothing with five senses.

6th-7th sessions (Emotion regulation)
Definition of emotion, how emotions work, familiarity with emotion regulation skills. Emotion Identification Exercise, Emotion Registration Exercise. Identifying barriers to experiencing emotion in a healthy way and ways to overcome these barriers. Teaching creating short-term positive emotional experiences for experiencing positive emotional states. up phase. Consequently, DBT retention rates were significantly higher than psycho-education retention rates at post-treatment and follow-up.

Acceptability and appropriateness
To enable assessment of the acceptability and appropriateness of intervention, patients completed the AIM and IAM scales in the post-treatment phase.
The acceptability scores were 16

Participant characteristics
Participants' demographic variables are shown in Table 2. Analyses showed that there were no significant differences between the two groups regarding these variables. It should be noted that since over 97% of the participants were male from the beginning, the results were reported only for men.

Efficacy outcomes
The hypothesis of equal covariance matrices was The results of the intergroup test and intergroup relations are also presented in Table 3. As shown in Table 3, the effect levels for craving (F = 3 With regard to cessation, the results indicated that DBT achieved a higher rate of cessation than the control treatment in both the post-test and at followup, (Table 4) (p < 0.05). It was also found that among those who continued to use the drug, the number of use days per month in the post-test and the follow-up periods (two months) was significantly lower in the intervention group than the control group.

Discussion and conclusion
This study examined the feasibility, acceptability,

Conclusion
To conclude, DBT demonstrated adequate feasibility, acceptability, and appropriateness for patients with marijuana use disorder. Moreover, DBT also exhibited significant efficacy compared to the control group for achieving cessation and reducing emotion-related craving. Even in patients who could not achieve abstinence, DBT led to a reduction in marijuana consumption rates. These findings persisted at twomonth follow-up.

Limitations and future directions
Despite these positive results, the present study also has some limitations. First, in order to evaluate the most significant treatment components (such as mindfulness and distress tolerance), no groups received the third wave versions of other therapies (ACT or MBSR). This study only had a two-month follow-up period and could not conduct long-term evaluation due to the study site's medical and infrastructure conditions. It is recommended that future research should examine mediating and confounding variables to investigate the results of similar research to the present study. Other factors affecting relapse and recurrence could also be examined. Moreover, women should be investigated so that gender-related implications can be determined.